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BOSTON 

PUBLIC 

UBRARY 




FEDERAL RESPONSE TO AIDS 



HEARINGS 

BEFORE A 

SUBCOMMITTEE OF THE 

COMMITTEB ON 

GOVERNMENT OPERATIONS 

HOUSE OF REPRESENTATIVES 

NINETY-EIGHTH CONGRESS 

FIRST SESSION 



AUGUST 1 AND 2, 1983 



T 



Printed for the use of the Committee on Government Operations 




FEDERAL RESPONSE TO AIDS 



At^w^iW <jTciMa ' 



HEARINGS 

BEFORE A 

SUBCOMMITTEE OF THE 

COMMITTEE ON 

GOVERNMENT OPERATIONS 

HOUSE OF REPRESENTATIVES 

NINETY-EIGHTH CONGRESS 

FIRST SESSION 



AUGUST 1 AND 2, 1983 



Printed for the use of the Committee on Government Operations 




U.S. GOVERNMENT PRINTING OFFICE 
26-097 O WASHINGTON : 1983 






COMMITTEE ON GOVERNMENT OPERATIONS 
JACK BROOKS, Texas, Chairman 



DANTE B. FASCELL, Florida 
DON FUQUA, Florida 
JOHN CONYERS, Jr., Michigan 
CARDISS COLLINS, Illinois 
GLENN ENGLISH, Oklahoma 
ELLIOTT H. LEVITAS, Georgia 
HENRY A. WAXMAN, California 
TED WEISS, New York 
MIKE SYNAR, Oklahoma 
STEPHEN L. NEAL, North Carolina 
DOUG BARNARD, Jr., Georgia 
BARNEY FRANK, Massachusetts 
TOM LANTOS, California 
RONALD D. COLEMAN, Texas 
ROBERT E. WISE, Jr., West Virginia 
BARBARA BOXER, California 
SANDER M. LEVIN, Michigan 
BUDDY MacKAY, Florida 
MEL LEVINE, California 
MAJOR R. OWENS, New York 
EDOLPHUS TOWNS, New York 
JOHN M. SPRATT, Jr., South Carolina 
JOE KOLTER, Pennsylvania 
BEN ERDREICH, Alabama 

William M. Jones, General Counsel 

John E. Moore, Staff Administrator 

John M. Duncan, Minority Staff Director 



FRANK HORTON, New York 

JOHN N. ERLENBORN, Illinois 

THOMAS N. KINDNESS, Ohio 

ROBERT S. WALKER, Pennsylvania 

LYLE WILLIAMS, Ohio 

WILLIAM F. CLINGER, Jr., Pennsylvania 

RAYMOND J. McGRATH, New York 

JUDD GREGG, New Hampshire 

DAN BURTON, Indiana 

JOHN R. McKERNAN, Jr., Maine 

TOM LEWIS, Florida 

ALFRED A. (AL) McCANDLESS, California 

LARRY E. CRAIG, Idaho 

DAN SCHAEFER, Colorado 



Intergovernmental Relations and Human Resources Subcommittee 

TED WEISS, New York, Chairman 
JOHN CONYERS, Jr., Michigan ROBERT S. WALKER, Pennsylvania 

SANDER M. LEVIN, Michigan ALFRED A. (AL) McCANDLESS, California 

BUDDY MacKAY, Florida LARRY E. CRAIG, Idaho 

EDOLPHUS TOWNS, New York 
BEN ERDREICH, Alabama 



JACK BROOKS, Texas 



Ex Officio 

FRANK HORTON, New York 
James R. Gottueb, Staff Director 
Susan Steinmetz, Professional Staff Member 
Gwendolyn S. Black, Secretary 



(II) 



CONTENTS 



Hearings held on — Page 

August 1 1 

August 2 255 

Statement of — 

Apuzzo, Virginia M., executive director, National Gay Task Force 17 

Bove, Dr. Joseph R., professor of laboratory medicine, Yale University 

School of Medicine, and director, blood bank, Yale-New Haven Hospital 162 
Brandt, Dr. Edward, Assistant Secretary for Health, Department of 
Health and Human Services, accompanied by Dr. William Foege, Direc- 
tor, Centers for Disease Control; Dr. Jane Henney, Deputy Director, 
National Cancer Institute; Dr. Anthony Fauci, Deputy Clinical Director 
of Intramural Research, National Institute of Allergy and Infectious 
Diseases; Dr. Amoz Chernoff, Director, Division of Blood Diseases and 
Resources, National Heart, Lung, and Blood Institute; Dr. Gerald Quin- 
nan, Director, Division of Virology, Office of Biologies, Food and Drug 
Administration; and Thomas Donnelly, Assistant Secretary for Legisla- 
tion, Department of Health and Human Services 292 

Brownstein, Alan P., executive director. National Hemophilia Foundation 50 

Callen, Michael, New York City 5 

Collins, Christopher J., cooperating attorney. Lambda Legal Defense and 

Education Fund 206 

Compas, Dr. Jean-Claude, vice president, Haitian Medical Association 

Abroad 41 

Conant, Dr. Marcus, professor of dermatology. University of California 

Medical Center, San Francisco, Calif 98 

Daire, Harold P., founder and director, Oaklawn Counseling Center, 

Dallas AIDS Project, Dallas, Tex 191 

Endean, Stephen R., executive director, Gay Rights National Lobby 38 

Ferrara, Anthony, Washington, D.C 7 

Krim, Dr. Mathilde, associate member, head of interferon laboratory, 

Sloan-Kettering Institute for Cancer Research, New York, N.Y 126 

Lyon, Roger, San Francisco, Calif 6 

Matek, Stanley J., immediate past president, American Public Health 

Association 273 

Rosen, Mel, Gay Men's Health Crisis, New York City 177 

Sencer, David J., M.D., M.P.H., commissioner of health, New York City, 

N.Y 258 

Siegal, Dr. Frederick P., chief, division of clinical immunology. Mount 

Sinai School of Medicine and City University of New York 117 

Silverman, Mervyn F., M.D., M.P.H., director of health, San Francisco, 

Calif 270 

Voeller, Dr. Bruce, president, the Mariposa Education and Research 

Foundation 151 

Weiss, Hon. Ted, a Representative in Congress from the State of New 
York, and chairman, Intergovernmental Relations and Human Re- 
sources Subcommittee: Opening statement 1 

Letters, statements, etc., submitted for the record by — 

Apuzzo, Virginia M., executive director, National Gay Task Force: Pre- 
pared statement 22-37 

Bove, Dr. Joseph R., professor of laboratory medicine, Yale University 
School of Medicine, and director, blood bank, Yale-New Haven Hospi- 
tal: Societal and medical risks 165 

(HI) 



IV 

Letters, statements, etc., submitted for the record by Continued 

Brandt, Dr. Edward, Assistant Secretary for Health, Department of 
Health and Human Services: p 

Budget figures describing support for science base research related to "^ 

AIDS 470-472 

Centers for Disease Control budget figures by year ^ 384 

Correspondence concerning current research efforts on AIDS 392-410 

Investigator initiated research project grants 481 

List of meetings and those in attendance ooa qoc 

Prepared statement ■■:".•■" 298-d-ib 

Brownstein, Alan P., executive director. National Hemophilia Founda- 
tion: „„ 

Information concerning research cq_ co 

Prepared statement ,"V^' "A V ^^""^ 

Collins, Christopher J., cooperating attorney. Lambda Legal Defense and 

Education Fund: Prepared statement 210-25Z 

Compas, Dr. Jean-Claude, vice president, Haitian Medical Association 
Abroad: ,, 

Papers and articles '^ ^^ 

Conant, Dr. Marcus, professor of dermatology. University of California 

Medical Center, San Francisco, Calif: Prepared statement 103-llb 

Daire, Harold P., founder and director, Oaklawn Counseling Center, 

Dallas AIDS Project, Dallas, Tex.: Prepared statement 194-205 

Foege, Dr. William, Director, Centers for Disease Control, Department of 
Health and Human Services: 

Correspondence between subcommittee and departments dZo-dbi 

Memorandum concerning confidentiality of AIDS survsillance data: 

Current systems for collection and protection of data 3b5-d7d 

Krim, Dr. Mathilde, associate member, head of interferon laboratory, 
Sloan-Kettering Institute for Cancer Research, New York, N.Y.: Pre- 
pared statement •;;-v:r-"u"i..i 

Matek, Stanley J., immediate past president, American Public Health 
Association: Prepared statement 276-275 

Rosen, Mel, Gay Men's Health Crisis, New York City: 

Case report prepared by Dr. Irving Selikoff icoiqn 

Prepared statement •■• ...........^.. lo-i-iyo 

Sencer, David J., M.D., M.P.H., commissioner of health, New York City, 

N.Y.: Attachments to statement •••••••• 2bl-270 

Siegal, Dr. Frederick P., chief, division of clinical immunologj'. Mount 
Sinai School of Medicine and City University of New York: December 
10, 1981, article from the New England Journal of Medicine entitled 
"Severe Acquired Immunodeficiency in Male Homosexuals, Manifested 
by Chronic Perianal Ulcerative Herpes Simplex Lesions" 119-124 

Voeller, Dr. Bruce, president, the Mariposa Education and Research 

Foundation: Prepared statement lob-lbl 

APPENDIXES 

Appendix 1.— HHS response to subcommittee questions 487 

Appendix 2.— Material submitted for the record • o^l 



FEDERAL RESPONSE TO AIDS 



MONDAY, AUGUST 1, 1983 

House of Representatives, 
Intergovernmental Relations 
AND Human Resources Subcommittee 
OF THE Committee on Government Operations, 

Washington, D.C. 
The subcommittee met, pursuant to notice, at 10:05 a.m., in room 
2154, Rayburn House Office Building, Hon. Ted Weiss (chairman of 
the subcommittee) presiding. 

Present: Representatives Ted Weiss, Sander M. Levin, Robert S 
Walker, Alfred A. (Al) McCandless, and Larry E. Craig. 
Also present: Representative Barbara Boxer. 
Staff present: James R. Gottlieb, staff director; Susan Steinmetz, 
professional staff member; James F. Michie, chief investigator; 
Gwendolyn S. Black, secretary, and Hugh Coffman, minority pro- 
fessional staff. Committee on Government Operations. 

OPENING STATEMENT OF CHAIRMAN WEISS 

Mr. Weiss. Good morning. 

The subcommittee will come to order. 

Let the record show that a quorum was present. We have Mr. 
Walker, who is the ranking minority member on the committee to 
my immediate right, Larry Craig at the end of the table on my 
right, and Barbara Boxer on my immediate left. 

I would like to begin this hearing by extending my appreciation 
to the many witnesses who have traveled here from across the 
country to express their concerns about acquired immune deficien- 
cy syndrome [AIDS] and the Federal Government's response to this 
public health emergency. 

The AIDS epidemic continues its cruel relentless pace. The most 
recent data from the Centers for Disease Control reveals almost 
2,000 reported cases and 730 fatalities in this country alone. The 
number of cases is still doubling every 6 months. The young age of 
the victims and the debilitating nature of the disorder deepens the 
human tragedy of AIDS. And there is little sign that researchers 
are close to unraveling the mystery of the epidemic. 

For far too long our collective response, societal as well as gov- 
ernniental, to the crisis was haphazard and inexcusably slow. But 
within the last few months, the consensus for urgent and exhaus- 
tive action has solidified. The Federal Government, in fulfilling its 
duty to protect the Nation's health and safety, must mobihze its 
enormous resources to meet this challenge as quickly as possible. 
Moreover, Congress, the administration, and the Public Health 

(1) 



Service must act aggressively to provide care and compassion to 
the victims with respect to their right to confidentiaUty. 

This forum will enable representatives from many groups in- 
volved with AIDS to share their concerns and insights about the 
epidemic with Federal officials. At the same time, it will afford the 
administration an opportunity to describe its activities and respond 
to concerns that may be raised. I believe that such an exchange 
will increase Government responsiveness to those affected by its 
decisions. In this situation, the quality of these decisions may de- 
termine whether people live or die. 

As part of this subcommittee's oversight responsibilities, we have 
initiated an inquiry into the Department of Health and Human 
Services' efforts to extinguish the epidemic. Unfortunately, the re- 
fusal of the Department to provide full access to its staff and 
records has seriously hampered our oversight work. However, 
during our preliminary inquiry, many issues have emerged which 
will be addressed during these hearings. These include: 

Are adequate resources available for research, treatment, and 
prevention? 

How comprehensive are the research and surveillance activities? 

Has the Government's response been timely? 

What is the extent of coordination in the efforts to fight the epi- 
demic? 

What is the scope of public education and how effective is it? 

How accessible is health care for persons with AIDS? 

Is the confidentiality of those who suffer from AIDS being pro- 
tected? 

In the course of our preliminary oversight work, CDC has sug- 
gested that their unwillingness to cooperate with this subcommit- 
tee was based largely on confidentiality. There is no justification 
for this excuse to deny Congress complete access to information on 
the agency's AIDS activities. 

I want to make it unquestionably clear, as I have to the Depart- 
ment, that the subcommittee has no interest or intention of collect- 
ing names or other identifying information regarding individual 
patients. There is serious concern whether CDC should even have 
this information as long as there are alternative procedures in 
place to assure adequate research. It is my understanding that 
CDC is in the process of developing such a system so that it will no 
longer be necessary for any agency at the Federal level to maintain 
such records. 

I believe that there is a strong need to assure that the confiden- 
tiality of all patients and research participants is preserved, and I 
am exploring several possible legislative remedies, similar to the 
provisions already contained in the Federal law to protect partici- 
pants in drug abuse and prevention activities. 

The growing sense of national emergency that has catapulted 
AIDS into the headlines has also intensified the fight against the 
epidemic. Unfortunately, at the same time rumors and misconcep- 
tions have unleashed a public panic that diverts attention from the 
real needs. The epidemic has even been used as an excuse to 
malign gays and Haitians and to disregard their fundamental 
human rights. The best way to counter the hysteria and prejudice 
is to provide the public with accurate and timely information. I am 



confident that this hearing will help disseminate this needed infor- 
mation. 

Before we ask our first set of witnesses to testify, I would like to 
ask the other members, starting with Mr. Walker, for whatever 
opening statements they would care to make. 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Chairman, acquired immune deficiency syndrome, commonly 
known as AIDS, is a serious public health problem. Determined 
systematic research, accurate communication and intense coopera- 
tion between Government, private citizens, scientists, and commu- 
nity groups will be necessary to insure a timely resolution of the 
AIDS threat. 

I am hopeful, Mr. Chairman, that during the next 2 days of hear- 
ings, we can help focus attention on what has been done to discover 
the cause of AIDS and what can be done to eradicate this unfortu- 
nate condition. It is important that we strive to avoid engaging in 
hysteria and harangues that serve only to scare the public. 

There seems to have been a tendency to speak out first about 
AIDS and check the facts later. Jay Winsten, director of the Office 
of Health Policy Information at the Harvard School of Public 
Health, has written: 

"Public health information — and misinformation — has a power- 
ful effect on society, and the few highly inflammatory news reports 
on AIDS has done considerable damage." 

Winsten adds: 

"The absence of concrete information on AIDS, its cause, its 
mode of transmission and the extent to which it might spread, per- 
mits public fears to grow unrestrained." 

For a variety of reasons the homosexual community and the pop- 
ular media chose to focus extraordinary attention on AIDS. Unfor- 
tunately, the resultant hysterical reaction in some segments of our 
society has been an undesirable and unneeded result. 

We should not lose sight of a simple fact. With the knowledge 
they have now, medical researchers will readily state that most 
people are not going to get AIDS. Homosexual males, particularly 
those with very high numbers of sexual liaisons, intravenous drug 
abusers and users, hemophiliacs, and Haitians are the groups at 
risk. Let me emphasize that we need to protect these people, we 
need to help them, but AIDS is not spreading widely on a geo- 
graphic or demographic basis. 

We want an AIDS cure; we need AIDS prevention. If counselors, 
sensitive to the affected communities, must speak to lifestyle issues 
to help prevent AIDS, I urge them to do it. Topics like sexual activ- 
ity or drug abuse are never comfortably discussed but doctors, 
mental health officials, and community counselors must be pre- 
pared to do so if it can mean one less person with AIDS. 

I spoke of a cure, and I believe we will eventually solve this 
medical mystery. It will be done, most likely, by painstaking re- 
search and through an accumulation of knowledge. We should be 
careful to avoid the inevitable push for more money as if dollars 
are a magic potion. 

Let's let our scientists work. We can prod them, but let us allow 
for the time needed to get all the facts; let us have the necessary 
peer review and let us have the studies and exchange of informa- 



tion that will eliminate this awful problem. More money may be 
needed but let us use our resources wisely. 

Attention has certainly been focused on AIDS. Research is un- 
derway within Federal agencies and in university and private labo- 
ratories. Let us maintain our perspective, deal in facts, and hope 
for the earliest possible resolution of this unfortunate problem. 

Thank you, Mr. Chairman. 

Mr. Weiss. Thank you very much, Mr. Walker. 

Before we proceed, I indicated previously that Mrs. Boxer, who is 
a member of the full committee, is with us. We have also been 
joined by Mrs. Burton of California. We may have other members 
join us during the course of these hearings today and tomorrow. 

Without objection, I would like permission from the subcommit- 
tee to allow any members on the full committee or Members of the 
House to join with us and to participate to the extent that their 
time permits. Without objection, it is so directed. 

Let me ask at this point Mr. Craig if he has any comments to 
make. 

Mr. Craig. I compliment you on holding these hearings. I think 
that Mr. Walker has stated both the obvious and the necessary as 
it relates to this most critical national problem. I hope that this 
hearing, and those who attend and participate in this hearing over 
the next couple of days, will focus not only on what we are current- 
ly doing, but what must be done to bring this problem within the 
bounds of control, and hopefully to find a solution and a cure to 
this disease. 

From what I have heard and am now aware of, there appears to 
be a growing national hysteria that need not continue if the kind 
of information that can go forth from this hearing is allowed to go 
forth and is responsibly reported in the press. It cannot be treated 
in that way if we are to bring it to a conclusion and allow the agen- 
cies of this Government, who are now pouring millions of dollars 
into the necessary and appropriate research for this problem, are 
allowed to address it in the only way they can, as it relates to 
medical science and the proper procedures for bringing this prob- 
lem to a conclusion. 

I hope that is the goal of this hearing. If it is handled and con- 
ducted in a responsible fashion, that certainly can be the outcome, 
and we can be direct participants in solving this most important 
national problem, Mr. Chairman. 

Thank you. 

Mr. Weiss. Thank you, Mr. Craig. 

Mrs. Boxer? 

Mrs. Boxer. Thank you. 

I want to thank the members of the committee for allowing me 
to participate in this particular subcommittee hearing on a subject 
that is very close to my heart and to my congressional district. I 
want to thank the chairman for holding these hearings and for the 
leadership he has shown in fighting this disease, and I have worked 
with him on many bills. 

The tragedy of AIDS disease is very well known, as I said, to my 
congressional district. But only with the understanding of Members 
of Congress from all over this country will we be able to win this 
fight. 



Recently the Congress appropriated $12 million for AIDS re- 
search. We need to do more. Dollars will have to fund this research 
just as dollars funded research for all other baffling disease. 

These hearings give us an opportunity to examine how well our 
Government is responding, and what more we can do to ease the 
pain and ease the fears of the American people and, above all, help 
to find the cause and cure of AIDS. 

Thank you, Mr. Chairman. 

Mr. Weiss. Thank you, Mrs. Boxer. 

We have just been joined by one of the more active members of 
the subcommittee, Mr. McCandless. 

Would you care to make an opening comment? 

Mr. McCandless. Thank you very much, Mr. Chairman. 

I have no statement at this time. 

Mr. Weiss. Thank you. 

I think we are ready to proceed at this point with the hearing. 

I think the best place to begin is to hear from witnesses who are 
struggling each day with the terrifying prognosis of AIDS, the 
names and faces behind the statistics announced each week. They 
are here to share their personal and unique experiences, to help 
the Government become more responsive and sensitive to their 
needs, and to participate in the decisionmaking that affects their 
survival. 

We are an oversight and investigative committee. We administer 
an oath or affirmation to each of our witnesses. 

So first let me introduce the three of you: Michael Callen of New 
York, Roger Lyon of San Francisco, and Anthony Ferrara of Wash- 
ington, D.C. 

We want to welcome each of you on behalf of the subcommittee. 
We very much appreciate your willingness to come before this sub- 
committee and share with us your personal experiences and 
thoughts regarding this epidemic. 

I would appreciate if you would all stand at this point, raise your 
right hands. 

Do you affirm to tell the truth, the whole truth, and nothing but 
the truth? 

Let the record indicate each of the witnesses has nodded affirma- 
tively. 

Thank you. 

We have asked you, instead of submitting prepared statements, 
as is the usual course, if you would simply each briefly recount 
your own story of being diagnosed and describe the emotional and 
physical dimensions of the change in your life. If we may, let us 
begin with you, Mr. Callen. 

STATEMENT OF MICHAEL CALLEN, NEW YORK CITY 

Mr. Callen. In December of 1981 I had some blood testing done 
by my private physician, and those tests indicated that I was 
immune deficient. In December of 1981 there was very little known 
about this disease, but there was in the gay press beginning to be 
reports of increased instances of very unusual diseases, and they 
outlined some of the symptoms. I was very concerned because I had 
some of these symptoms — fevers, night sweats, general lymphade- 



nopathy, swelling of the lymph nodes, malaise, fatigue. So I had 
myself tested and, as I indicated, in December of 1981 I was told I 
was immune deficient. 

The effect of being told that I was immune deficient was devas- 
tating. I called my parents and said "I am going to die." I was not 
hospitalized until the summer of 1982, when I was diagnosed with 
cryptospordiosis, which is one of the qualifying opportunistic infec- 
tions according to the CDC definition of this syndrome. 

I was hospitalized for over a week with what is known as the 
wasting syndrome. It was the lowest point of my life. I was con- 
vinced from everything I read and heard that I was going to die. 
But I recovered from that specific infection, and I was rehospita- 
lized in the fall of 1982. They suspected Pneumocystis pneumonia. I 
had a bronchoscopy performed and other tests. It turned out to be 
bronchitis. But my story really illustrates one of the consistent sto- 
ries for people who have this syndrome. So little is known. 

When my doctor indicated to me in December of 1981 that I was 
immune deficient I said, "What does that mean?" And he said, 
"We don't know." So now a lot of people who are being told they 
are immune deficient are simply waiting, waiting for the next in- 
fection. 

Now, I have come to believe that I am going to beat this disease. 
I no longer think that I am going to die. But it is very difficult 
when you pick up newspapers or turn on the television and you 
hear that no one has fully recovered from this syndrome, and that 
80 percent of those diagnosed with the syndrome are dead after 2 
years. 

So I guess that is my story — waiting around for infections, check- 
ing myself every morning for Kaposi's sarcoma lesions and waiting 
for information about this disease to be forthcoming. 

Mr. Weiss. Thank you very much, Mr. Callen. 

Mr. Lyon. 

STATEMENT OF ROGER LYON, SAN FRANCISCO, CALIF. 

Mr. Lyon. Thank you, Mr. Chairman. 

I was diagnosed with Kaposi sarcoma on February 3 of this year. 
Prior to that time I was having absolutely no AIDS-related symp- 
toms whatsoever. On physical exam at that time three lesions were 
found internally. Prior to that I was being treated for an amoebic 
disorder, no real symptoms of AIDS. 

February 3, basically 100, I think more exactly 180 days ago, I 
became aware I had a life-threatening disease. February 4 I en- 
tered UC, I went to University of California without an appoint- 
ment, at the suggestion of my doctor, and started what is called 
their staging process — a battery of tests to determine the extent of 
this disease. At that time I was basically numb. I had no feeling. I 
was just moving. UC has been — they have been very kind and help- 
ful. 

One of the tests that is used to determine the extent of a disease 
today diagnosed as Pneumocystis pneumonia, which my doctor was 
100 percent sure I had, was a bronchoscopy. 

On February 28 I went in for a bronchoscopy, which is basically 
an invasive procedure, a lung biopsy. At that time the doctors took 



six biopsies. One of the biopsies, unfortunatley, gave me a pneumo- 
thorax, collapsed my lung, and at that time I was hospitalized for 4 
days. Also, at this time my family was visiting, they had no idea of 
what was going on, did not at that time even know that I was gay. 
So the first time they saw me was in the hospital with chest tubes, 
and they were quite concerned. Fortunately for me, they took ev- 
erything as well as— better than I could ever expect. They were 
wonderful. 

Since then I have gone through the staging process, upper and 
lower endoscopies, other invasive procedures. They wanted to do 
lymph node biopsies to determine whether it is in the lymph nodes 
but I refused. Fortunately, I hve been very lucky. The disease, the 
Kaposi's sarcoma, has not spread. There were three lesions, one 
was biopsied. The remaining two appear to have disappeared, gone 
into remission. That does not mean I do not have AIDS. Basically 
that means I do not have symptoms of Kaposi's sarcoma at this 
time. But my immune system is still very suppressed and extreme- 
ly susceptible to many opportunistic infections. 

Since that time, in late April I came down with a very severe 
shortness of breath. The doctor again thought I had Pneumocystis 
pneumonia. Fortunately, he was only 80 percent sure at this time. I 
was convinced that it was not. They did another bronchoscopy and 
they found cytomegalovirus. That was all. Since then, that has 
cleared up, and I have been very fortunate that no other symptoms 
have appeared. 

However, it is a matter of day-to-day waiting, waiting for some- 
thing to happen, living in constant fear that I am going to wake up 
one morning to find lesions, waking up finding that I have some 
other opportunistic infection, cryptospordiosis, possibly Pneumocys- 
tis pneumonia. 

At this time I am basically living in fear of what is to come. 
Other than that, it is a day-to-day wait-and-see process. 

Mr. Weiss. How old are you? 

Mr. Lyon. 34. 

Mr. Weiss. Mr. Callen, how old are you? 

Mr. Callen. 28. 

Mr. Weiss. Mr. Ferrara? 

Mr. Ferrara. 30. 

Mr. Weiss. If you will respond to the question that we asked. 

STATEMENT OF ANTHONY FERRARA, WASHINGTON, D.C. 

Mr. Ferrara. The first idea there was something wrong with me 
was last summer. I had lymphadenopathy, swollen lymph glands 
especially around the jaws and throat and under the arms. That 
continued for a few months, but the whole time I felt quite good. I 
continued to run and jog and I experienced no fatigue, no night 
sweats, no fevers. In fact, in November, I finished the Marine 
Corps marathon, when I was supposedly very, very ill. 

The lymphadenopathy went away. So I thought nothing further 
of it. But all along, I had been reading about AIDS, and of course, 
as every conscious gay man should be, was very worried about it. 

In February, I saw two small purple lesions, one on the inner 
aspect of each of my lower thighs, and I knew what they were, or I 



8 

knew what they could be, and I said I would wait a month and if 
they were still there in a month I would seek treatment or seek a 
diagnosis. Well, in the beginning of March they were still there. 

I belong to the George Washington University HMO. I went 
there and told them that they really should biopsy one of these le- 
sions to see what it was, gave them my sexual history and told 
them that there was a good chance I did have AIDS. They biopsied 
it, and the diagnosis was Kaposi's sarcoma. That was March 8. 

Obviously the first day I was very, very upset, and I went into a 
deep depression for about a month. I came home that night and my 
significant other held me in his arms, and I said to him, "Why do I 
feel like Ali McGraw, it is just like a movie, it is really terrible, it 
is the most horrible thing that ever happened." 

My depression lasted a month, and I decided if there was any 
chance I was going to get over this, if I had any chance of surviving 
at all, I would have to have a more positive attitude and just con- 
tinue on, live my life as best I can, and try to not worry about it 
too much. 

I was very lucky. I had the choice of being treated at GW by a 
very good cancer specialist there, who instilled a great deal of con- 
fidence in me, or I had the choice of being treated at the National 
Institutes of Health. I think it was an easy choice, because I 
think— NIH wanted me because I was so healthy at that point. I 
was a good specimen for research I think. And also, I felt that if I 
have the disease and no one knows anything about it, the best 
place to be treated would be where they are doing the research. 

The choices were being treated at GW, with a mild form of chem- 
otherapy called VP-16, which now is thought doesn't have much 
effect on Kaposi's sarcoma, or being treated with interferon at 
NIH. So I have been on and off at NIH since then. I have gone 
through two protocols, one was alpha interferon, and the second 
was gamma interferon. Both are made from blood cells, one is 
made — the gamma interferon is made from the immune blood cells 
themselves, that is my understanding. 

I am going to go back. In fact when I leave here today I am going 
back there and probably going to spend the next 6 weeks doing a 
third protocol, 2 to 3 weeks of plasma pheresis, and then interleu- 
ken 2, which has been getting a lot of press lately. And that brings 
me to today. 

Mr. Weiss. Thank you very much. 

Because I know that all of my colleagues on the panel will have 
numerous questions and because we have a large number of wit- 
nesses, I am going to defer further questions on my part and begin 
the 5-minute questioning phase. At the end of the questioning, if 
there are still areas that you feel we have not touched on, I will 
give you an opportunity to come back and fill in whatever gaps 
exist. 

With that, if I may, let me ask Mr. Walker if he has questions. 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Ferrara, what has been the attitude of the nurses, the tech- 
nicians, and the officials at NIH toward you and the other persons 
with AIDS who are under treatment at NIH? 

Mr. Ferrara. I think the nurses and the doctors that deal with 
us the most, those in the Institute of Allergies and Infectious Dis- 



eases and in the National Cancer Institute, are invariably compas- 
sionate and helpful. The nurses and doctors take the minimal pre- 
cautions possible. 

When the nurses may come into contact with our blood, for ex- 
ample when they give us an IV, or they give us a shot, they will 
wear gloves. Other than that, very few precautions are taken, 
except handwashing when entering and leaving the room. The doc- 
tors very often do not use gloves to examine us. 

The doctors of course are researchers. So sometimes, because 
they are researchers, they are not really schooled in the best bed- 
side manner, but I think generally they are extremely compassion- 
ate. They are working very hard, many of the doctors are there 
from morning until late at night. They are as desperate to find a 
solution to this problem as we are. 

Mr. Walker. Some critics of the Federal response to AIDS have 
criticized the use of interferon, which you said you have been treat- 
ed with, and the potential of interleuken 2. I understand that you 
are going to undergo treatment with interleuken 2. Could you tell 
the subcommittee how you feel about the treatment that you have 
had with interferon, and then also whether you are optimistic or 
pessimistic about your upcoming treatment with interleuken 2? 

Mr. Ferrara. The first type of interferon, the alpha interferon, 
which I believe is being used elsewhere in the country, I felt had 
some effect. I felt that it stopped the spread of the Kaposi's. I felt 
that there was some remission. 

The doctors, however, felt that the response was not good enough 
to continue. They would like to see a 50 percent remission before 
they would continue with a particular drug. 

I think the problem with interferons is that there is very little 
known. They are still being experimented with. It is like penicillin 
when it was first discovered, they didn't know what dosage to give, 
they didn't know how to give it. I think that is the problem the 
doctors are experiencing with the interferon. I think there is hope 
there. 

The second type of interferon, whether it was the dosage or 
whether it was for other reasons, whether the drug itself simply 
did not work, there was a spread in my Kaposi's lesions. I felt that 
the gamma interferon had no effect at all. 

Obviously I am very, very hopeful for interleuken 2. Every AIDS 
patient clings to hope. And the laboratory results for interleuken 2 
are extremely good. The doctors feel it has the potential, although 
the results at this point are inconclusive — it has the potential of re- 
storing the immune system to near normal. 

My layman's understanding of what it does, and this might be 
more beneficial to you than what the doctors tell you, is that it es- 
sentially bypasses the T-4 cells, the helper cells, and it is the sub- 
stance that the T-4 cells emit to tell the other body cells to fight 
disease. An analogy would be insulin for diabetics. It would bypass 
the T-4 cells and have the effect that those cells would have on 
their own. 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Weiss. Thank you, Mr. Walker. 



10 

I want to take note of the fact that we have just been joined by 
another outstanding Member of the House on our committee, Mr. 
Levin of Michigan. Welcome. 

Mrs. Boxer. 

Mrs. Boxer. Thank you, Mr. Chairman. 

I wanted to ask the panel, if anyone can address this, if you feel 
that you are given enough information about the disease, and then 
the second part, do you think that the gay communities throughout 
the country, from your knowledge, are being given enough informa- 
tion so that they can perhaps make some changes in their life to 
try and avoid it. 

Would you comment on that? 

Mr. Callen. Well, I am still using the same information that I 
knew in early 1982 when people asked me questions about the dis- 
ease. As far as I can tell, there hasn't been much new information 
at all. Some members of my community appear to be numb, be- 
cause there hasn't been much new about the disease coming out 
from research centers. A lot of people just don't want to hear about 
it any more, and they say "when you have the cure, let us know." 

I think that certainly in New York City the gay community has 
been straining to make what little information there is available in 
a way that is accessible to the community, and organizations like 
the Gay Men's Health Crisis have done an outstanding job dissemi- 
nating what little information exists. 

Mrs. Boxer. Mr. Lyon. 

Mr. Lyon. In San Francisco it is very much the same experience 
as New York. There is no new information. Every bit of informa- 
tion that has come out has been very widely disseminated. People 
are hungry for information. The city government, the public health 
officials, the city of San Francisco have, as far as I am concerned, 
gone overboard and made information available. Public forums 
have been held. Many of the health care facilities have asked pa- 
tients and health care officials to come and explain, "tell us every- 
thing you know, give us the information in order that we can 
dispel many of the fears." 

The main problem is there is no new information. It is a rehash 
over and over and over again of the same information. 

Mr. Ferrara. I agree with Mr. Lyon. I believe the problem is 
more misinformation than lack of information. 

I do my best to do as much as I can to dispel misconceptions 
about the disease. People don't have to be afraid to be in the same 
room with us, people don't have to be afraid to swim in the same 
swimming pool. I believe that gay organizations across the country 
should be given more information concerning guidelines that can 
be disseminated to the gay community in terms of— in terms of 
ways that gay men can protect themselves from the disease, rather 
than causing the paranoia and hysteria that the information that 
has been disseminated so far has caused. 

Mrs. Boxer. Do I have time for one last question? 

Do you find that you have a support system out in your commu- 
nities to help you get through this experience? 

Mr. Ferrara. Shall I start? 

Yes. Personally, my support system is quite good. I have a lover 
who has been very supportive and very loving. I have good friends 



11 

who help me a great deal. No one has shunned me. My employers 
have been very good to me. They have given me a parking space 
downtown so I won't have to ride on the Metro. 

I believe the gay community can do more to provide support 
services for people who are stricken with the disease. I think part 
of the problem there is again a lack of information. 

The gay groups in Washington are having great difficulty finding 
out who needs help. I think there must be more coordination be- 
tween the hospitals who treat AIDS patients and the gay communi- 
ty support services. There is a problem there of course with doctor- 
patient confidentiality. But I believe that can be gotten around by 
having the hospitals involved and the doctors involved make the 
patients aware that these support services are available. 

For example, the doctors and the nurses at NIH are very com- 
passionate and very supportive. But they are not gay. They don't 
understand the special psychological needs of gay people. The gay 
community can help there, and I believe that many of the hospitals 
who are treating AIDS patients are hindering those efforts. 

I believe that information can be disseminated and without 
breaching the doctor-patient confidentiality problem. 

Mr. Callen. I cofounded a support group called Gay Men With 
AIDS, which is run by those of us gay men who have been diag- 
nosed with the syndrome. It has made the difference for me. It is 
really what relieved some of the fear on a day-to-day basis. I saw 
other people fighting for their lives. We share information, we talk 
about doctors, hospitals, and treatments. For me AIDS was another 
closet, was another coming out. 

When I was first diagnosed there wasn't the terrible stigma that 
is attached to being diagnosed with AIDS now. So it never occurred 
to me not to identify myself to my friends as having the disease. 
But since that time, because of a lot of the misinformation and 
often hysterical coverage in the media, I know a number of people 
who refuse to identify themselves to their community, even to their 
family, as having the syndrome, because there is such tremendous 
stigma and isolation attached to it. 

But my support group meets in my living room, because there 
isn't any other space. I know in New York City we are trying to get 
a community center, but apparently we are going to have to raise 
$2 million to purchase it. 

I am a member of another support group which meets in the 
cramped offices of the National Gay Task Force. I am really glad 
they have made this space available. But it interrupts their activi- 
ties. We sit in the room where their hotline is. And people come 
and go. 

I think that there is a need for government to support the com- 
munity-based efforts in the various cities, to make support services 
available to people who need it. 

Mr. Lyon. My support system is primarily all private. Friends, I 
have a fantastic group of friends who have been behind me, in 
every decision that I have made all the way through. My family is 
right there also. 

There are also some other private groups. One I will mention, 
the Shanty Group, the AIDS-KS Foundation. Information? There 
are phone lines available if you want to call someone, if you want 



12 

to talk any time of the day, they are there. Primarily personal sup- 
port groups. Nothing that anyone else, including the Federal Gov- 
ernment, has set up. It is all personal. And I think those are the 
best support groups. 

Mrs. Boxer. Thank you, Mr. Chairman. 

Mr. Weiss. Thank you very much. 

Mr. McCandless. 

Mr. McCandless. Thank you, Mr. Chairman. 

Gentlemen, the Department of Health and Human Services has 
supplied us with statistics. I find them interesting and wish to 
throw them out for whatever value it may be. 

If you wish to comment, it might be of assistance to us, and par- 
ticularly me, in understanding the circumstances a little better. 

According to these statistics, the total cases reported, both 
United States and foreign, are approximately 2,100. Of these two- 
thirds are in the States of New York and California, with the 
greatest percentage in the metropolitan areas of New York City, 
San Francisco, and Los Angeles. 

Can you comment on why there is a concentration of cases in 
these areas with respect to the total figures, and the rest of the 
United States? 

Mr. Callen. Well, I am not an epidemiologist. I think it indicates 
there are many, many unusual features about this syndrome. It in- 
dicates the need for really high quality epidemiological research to 
explain the unusual pattern of this disease. And to date, none of 
the epidemiology has been published. 

One hears rumors that the epidemiology of the CDC was poorly 
constructed and poorly written. I don't know what the reason is, 
but I understand that they have had some difficulty finding a 
medical journal to publish the study. 

The question of epidemiology and why the disease seems to be 
clustered in large urban centers will tell us a lot about who gets 
this disease and who doesn't and why. And so I don't have any 
more answers than anybody else. But I am very, very eager for the 
epidemiology to be done and done right and done quickly. 

Mr. Weiss. May I indicate, although obviously the question is ab- 
solutely appropriate to these witnesses, there will be additional wit- 
nesses in panels later on who can address some of the expert areas. 

Mr. McCandless. Thank you. 

That is all I have at this time, Mr. Chairman. 

Mr. Weiss. Thank you, Mr. McCandless. 

Mr. Levin. 

Mr. Levin. I don't have any questions. 

Thank you for your testimony. 

Mr. Craig. 

Mr. Craig. Thank you very much. 

To all of you on the panel, thank you for your openness, your 
honesty and forthrightness in your testimony. It is critically impor- 
tant that you are willing to come forward and discuss this serious 
problem in the way you have— if we are to be participants here in 
helping. 

I have a couple of questions, I think reflective of how the gay 
community is responding. You mentioned earlier, some fears and 
concerns on your part and the community's part. 



13 

Has there been, or is there now, because of the fear of this dis- 
ease, an exodus if you will, from the areas or the communities Mr. 
McCandless talked about. New York and San Francisco specifically 
where the larger number of cases are reported. In places where it 
seems to be relatively well understood that there are large popula- 
tions in the gay community— have people left the community out 
of fear? Are they leaving? 

Would any of you respond to that, as best you can? 

Mr. Ferrara. Well, first of all, I think it is impossible to leave 
the gay community. You are either a member of the community or 
not. 

Mr. Craig. OK. That is a valid statement. 

What I am saying is, are the gays leaving the area in which they 
resided because of fear? 

Mr. Ferrara. I see. No, I don't think so. I think we are being 
much more careful about— they are much more worried. But I 
don't think there is a mass exodus from large urban areas. 

Mr. Lyon. I haven't seen or even considered the fact that there 
has been an exodus from any area. I think what we are finding 
within the gay community is a very strong bonding, a coming to- 
gether, a recognition of a problem. I think that it is strengthening 
the gay community. I don't see anyone leaving because of the fear 
of AIDS. 

Mr. Callen. Many of us go into these specific cities to escape the 
prejudice that we experience as gay and lesbian people. So where 
else are we going to go? Also, as was mentioned, our support sys- 
tems are in these cities — our jobs, where we will get our insurance. 
For most people there is not the option to go anywhere else. If you 
are an openly gay person— you have to— most gay people I know 
tend to congregate in large urban centers, because there is per- 
ceived to be greater tolerance. 

Mr. Craig. With those responses in mind, you say there is a 
growing bond, if you will, toward support and assistance within 
the community. Does the gay community view themselves as a 
direct participant in assisting in getting this problem under con- 
trol? Because— one of you made some comments earlier that there 
seems to be a reaction on the part of some — I don't want to hear 
any more about it, tell me when there is a cure, or tell me when 
there is new information, but until that point don't bother me. 

My reaction to that comment was that that would be very nega- 
tive to any assistance that a cooperative effort on the part of medi- 
cal science and the community working towards a solution to the 
problem. Is that a prevalent attitude in the community, or was it a 
reaction that is now turning about toward cooperation? 

Mr. Callen. I think there has been unprecedented cooperation 
from the community. If money were available for screening, I #iink 
you would have the entire community available. 

When I made the comment that there are some people who don't 
want to hear, the reason they don't want to hear is because there 
is no new information. They have already absorbed the old infor- 
mation, and they don't like to be beat over the head with the same 
old information. They have already made whatever adjustments 
that they plan to make to protect themselves from the disease, and 



26-097 0—83 2 



14 

a lot of people are very, very tired of dwelling on the tragedy of 
this disease. 

Mr. Craig. Thank you, Mr. Chairman. 

Mr. Weiss. Thank you, Mr. Craig. 

We have touched on the emotional and medical aspects of the 
disorder and your reactions to it. 

I wonder if we could touch just a bit on your professional or occu- 
pational background — how the syndrome has affected that, what 
kind of insurance coverage you have and who pays for the costs of 
your medical care. 

We know, Mr. Ferrara, that you are at NIH. But I wonder, Mr. 
Lyon and Mr. Callen, how you and others in your situation are 
coping with this particular aspect of the problem. 

Mr. Callen. Well, at the time I was initially diagnosed, I was a 
paralegal, and I had just changed jobs 3 months prior to my diag- 
nosis. I have about $6,000 in hospital bills that the insurance com- 
pany has declined to pay. They are claiming preexisting condition. 
It is unclear to me exactly why: whether they just are doing that to 
do it — as I understand some insurance companies do — or whether 
because the etiology of AIDS is so mysterious, they are going to 
claim that I had the syndrome at some point in the past. I am 
being chased by the hospitals for about $6,000. I don't know how I 
am going to pay it. 

Mr. Weiss. Mr. Lyon? 

Mr. Lyon. I work for a large leasing company. I am a sales repre- 
sentative. I am fortunate in the fact that I am still able to work. 
Many of the patients, many of my friends are totally unable to 
work. They are lucky if they can get up in the morning, shower, 
and go on about their daily activities. 

As far as the costs, to date my medical bills have run in excess of 
$11,000. And I am not on any treatment whatsoever, not antibiot- 
ics, nothing. It is all diagnostic. Fortunately, my insurance, private 
medical Insurance, has paid approximately 80 percent of that. That 
still leaves somewhere in the neighborhood of $2,500, $3,000 that I 
am responsible for. 

Many of the patients, I think far, far more of the patients, do not 
have the benefit of private medical insurance. Many are on disabil- 
ity. Many are now seeking social security which, thank God, has 
become available. It is, however, a very lengthy time-consuming 
process. So much of the costs to many of the patients is thrown 
back on the community as a whole. Many people are just indigent 
in this area. 

Mr. Weiss. Mr. Ferrara? 

Mr. Ferrara. I am also very lucky to be able to continue work- 
ing. I am a Federal employee. As I said before, I belong to the 
GWHMO. So it was — I was very lucky in the sense that either 
choice, either being treated by the HMO, which would cover all 
costs, or being treated at NIH would be for free. I haven't had to 
pay anything up to this point, except for a few dollars that the 
HMO didn't cover. 

However, I think part of the problem is the drugs involved are so 
extremely expensive, the experimental drugs. If any of them work, 
what my fear is is that, one, it is going to be too expensive to be 



15 

widely disseminated, and two, the experimental status of the drugs 
may cause insurance companies to avoid paying for them. 

Mr. Weiss. Has anyone at NIH indicated to you what your costs 
would be for the treatment and medication if in fact you were able 
to and had to secure care through private sources? 

Mr. Ferrara. If I had to pay for the drugs I receive at NIH, at 
this point — I am not sure about this, but from indications that I 
received, the cost of the drugs would have already exceeded half a 
million dollars. 

Mr. Weiss. Because of the experimental nature? 

Mr. Ferrara. Because of the experimental nature, and because 
the drugs very often at this point cannot be genetically engineered 
through the recombinant DNA method which is cheaper than cre- 
ating them by essentially having all these blood cells and cooking 
up the drug and letting the cells create the drug themselves. So 
that the processes to create these drugs now are extremely expen- 
sive. 

Mr. Callen. I think one can anticipate this problem of experi- 
mental treatment as being rejected for insurance coverage. I know 
of one instance where a friend of mine went for plasmapheresis. 
His insurance declined to cover that with the justification that any 
treatment for this disease is experimental because it is thought to 
be new. So there are no treatments of any proven efficacy. 

I think we can anticipate that increasingly insurance companies 
are going to decline paying for any treatment with the justification 
that it is all experimental. 

Mr. Weiss. Given the parameters of our hearing and the time- 
frame in which we are operating, that completes the questions that 
we have specifically directed toward you. 

However, I don't want you to go without giving each of you the 
opportunity to fill in whatever gaps you think we have left. If there 
is anything that you want this committee or the Congress or the 
American people to know about AIDS generally or a particular sit- 
uation, now is the time to do it. Any and all of you are welcome at 
this point to make closing comments. 

Mr. Lyon? 

Mr. Lyon. I came here today with the hope that this subcommit- 
tee would be able to do everything possible to halt the spread of 
this disease. AIDS has been called the number one health priority 
of the Nation. It certainly is my No. 1 priority. 

I came here today with the hope that this administration would 
do everything possible, make every resource available — there is no 
reason this disease cannot be conquered. We do not need infighting, 
this is not a political issue. This is a health issue. This is not a gay 
issue. This is a human issue. And I do not intend to be defeated by 
it. I came here today in the hope that my epitaph would not read 
that I died of redtape. 

Mr. Weiss. Thank you, Mr. Lyon. 

Mr. Ferrara? 

Mr. Ferrara. I think I would just like to say that there is prob- 
ably a limit to how much money the research community can 
spend on research for the disease. I think there are just so many 
minds that can go around and do so many experiments and spend 
so much money to try to find a cause, a cure, or a control. 



16 

Beyond research, I think if more funds are to be made available, 
a place where they can do a lot of good is in screening programs — 
moneys given directly to the gay community or organizations 
within the gay community that can set up this sort of thing, 
screening programs, to try and find out just how many people 
there are out there with the disease, and in that way halt the 
spread of the disease. 

Mr. Weiss. Thank you. 

Mr. Callen? 

Mr. Callen. Well, as a person with AIDS, I suffer in two basic 
ways. I suffer from the disease itself, and I suffer from the stigma 
attached to being diagnosed with this disease. The end to both as- 
pects of this suffering will come only if the vast resources of the 
Federal Government are turned on this problem. 

We need answers to the pressing questions of cause, cure, and 
contagion. And so the bottom line is, as it almost always is, money. 
But in order to make that money accomplish something, it has to 
be well spent. And I think that one of the things that is encourag- 
ing to me about this committee is that you have requested access to 
information from the governmental agencies dealing with this 
problem. 

I have yet to see a comprehensive plan of attack emerge from the 
Government. What do they plan to do, in what order? Is there a 
master plan for research which is guiding their funding requests? 
Are they developing an animal model? What treatment options are 
being pursued? Which have been discarded? Why? 

So the first priority is money. The second is that the money be 
well spent, and that will require that there be a very clear master 
plan. There needs to be some sort of accountability, which is what 
this committee is all about. 

I would also like to speak briefly to the issue of confidentiality, 
which is beginning to be mentioned more frequently in the context 
of AIDS research, and to clarify, because I think that the issue is 
often misunderstood. 

The issue of confidentiality is really two issues. As you know, the 
information being collected by the Centers for Disease Control in- 
volves basically very sensitive personal information. So there exists 
the potential for the political abuse of information collected in the 
context of surveillance. 

But the other more important issue of confidentiality, as I see it, 
is that we need to remove any and all obstacles to collecting accu- 
rate information. And the basic scenario is this: A representative of 
the Federal Government, a CDC representative, shows up at the 
bed of a person who has just been diagnosed with a life-threatening 
illness, and asks that person to admit to illegal acts — for example, 
drug abuse, sexual acts which are illegal in most States, acts of 
prostitution. Assuming for a moment that those questions are nec- 
essary to elucidate the etiology of this disease, one needs to create 
a situation where patients are likely to give truthful responses to 
be forthcoming with detailed information. 

And so the issue of confidentiality, as I see it, is simply reassur- 
ing communities which, as far as I can tell, have no reason to trust 
the Government blindly. We need to be reassured that the confi- 
dentiality of this very sensitive information is being protected. So I 



17 

view whatever measures have to be taken to insure confidentiality 
as justified in a cost-benefit sense. 

If you can assure people that the sensitive information being col- 
lected is being protected — that it cannot be used against them — you 
will encourage them to give more truthful responses; and truthful 
responses in turn will be more useful to researchers in terms of re- 
solving the mystery of AIDS. 

So to reiterate, money; money that is well spent; and sensitivity 
to the issues of confidentiality. I guess that is basically what I 
would like to see. 

Mr. Weiss. Thank you very much. 

I want to thank all of you on behalf of the subcommittee, the full 
committee, and the House. 

As Mr. Craig indicated before, we have nothing but admiration 
for your determination, perseverance, and courage, both in fighting 
the syndrome itself and in sharing your knowledge and experience 
with the rest of us. 

Thank you all very, very much. 

Our second panel consists of representatives from affected com- 
munities: Virginia Apuzzo, executive director, National Gay Task 
Force; Stephen Endean, executive director. Gay Rights National 
Lobby; Dr. Jean-Claude Compas, vice president, Haitian Medical 
Association Abroad, and Alan Brownstein, executive director, Na- 
tional Hemophilia Foundation. 

We will hold off questions until the witnesses have all completed 
their testimony. I know that you all have prepared written state- 
ments, and those will be entered into the record without objection, 
in their entirety. If you wish to highlight or summarize your re- 
marks, please feel free to do so. 

Again, if you will stand for the affirmation. 

Do you affirm that you will tell the truth, the whole truth, and 
nothing but the truth? 

Ms. Apuzzo. I do. 

Mr. Endean. I do. 

Dr. Compas. I do. 

Mr. Brownstein. I do. 

Mr. Weiss. We will begin with Ms. Apuzzo, then Mr. Endean, Dr. 
Compas, and Mr. Brownstein. 

STATEMENT OF VIRGINIA M. APUZZO, EXECUTIVE DIRECTOR, 
NATIONAL GAY TASK FORCE 

Ms. Apuzzo. My name is Virginia Apuzzo. 

I am grateful for the opportunity to testify today. But I am sad- 
dened and, yes, I am angered by the necessity, a necessity brought 
on by what we perceive to be the Federal Government's policy of 
gestures and not actions. 

Quite simply, from our point of view, Mr. Chairman, the Federal 
Government's response to the AIDS epidemic reveals that the 
health care system of the wealthiest country in the world is not 
equipped to meet the needs of its citizens in an emergency, howev- 
er brief or extended that emergency might be. 

Further, if we take a look at the Federal Government's response 
to the AIDS crisis it leads unavoidably to the conclusion that 



18 

within this administration, there is a sharp contrast between the 
rhetoric of concern and the reaUty of response. That failure is un- 
derscored when one looks at the record of the lesbian and gay com- 
munity in filling the gap. 

I was pleased to hear the number of questions posed about this. 
Perhaps I can add additional specifics to the extent to which the 
gay and lesbian community has indeed responded. 

The National Gay Task Force survey of community voluntary or- 
ganizations found that $2.3 million was budgeted for AIDS projects 
in 1983 for the gay and lesbian community, with another $6.8 mil- 
lion being projected and budgeted for 1984 in the gay and lesbian 
community. These figures do not include local and State govern- 
ment grants to these groups, nor do they include the value of hun- 
dreds of thousands of voluntary hours in these programs. 

Indeed, the National Gay Task Force last October opened up a 
crisis line, an 800 number, that would enable members of the com- 
munity and the public at large to seek information about AIDS. We 
are getting in excess of 3,000 calls a day that we cannot respond to. 
And we are open 8 hours a day, 5 days a week, until 9 o'clock at 
night, so that we can take care of the concerns and the questions 
from the Western part of the country. 

Our community, is proud of this response. But our experience in 
the front lines tells us that we cannot be expected to solve this 
crisis on our own. Our Government must respond to our needs. 

We have found the administration has been out of touch with the 
magnitude of the crisis. It has been following, not leading the gen- 
eral public and the affected communities. In hearings before Con- 
gressman Waxman's subcommittee. Dr. Brandt admitted that the 
fiscal 1984 budget which showed less money for AIDS work than in 
1983 was "prepared before we understood in fact how much money 
it would require." 

That belated recognition is shocking enough. What is inconceiv- 
able is that the administration has yet to adjust its 1984 budget re- 
quest. 

More than 2 years after this medical crisis became generally rec- 
ognized, the administration still has not presented a comprehensive 
plan of attack. Mr. Callen said it as eloquently as it could be said. 

More than 2 months ago I wrote a letter to Secretary Heckler 
asking her to set forth just such a plan. She has been unable or 
unwilling to do so. 

My written testimony submitted to your committee details the 
failures of the Federal Government's response in, first, setting out 
requests for research projects to study AIDS, second, in funding 
those projects which pass its review programs, and third, in even 
identifying such crucial study areas as the cause or etiology of 
AIDS, now set for funding for the first time, Mr. Chairman, in Oc- 
tober of 1983. 

When you look at how NIH is handling the funding of research, 
what is driven home time and time again is that we lack the re- 
sources to do the job, even if you accept the administration's more 
limited view of what needs to be done. 

In point of fact, there are now more requests for applications out 
than money appropriated to fund them. Even the NIH bureaucracy 
recognizes a greater need than the budget cutters at 0MB. $9.6 



19 



million was appropriated for NIH for basic research on AIDS, in 
tiscal iy8d. State and local governments along with the private 
sector are coming close to matching that figure on their own That 
is a very sad commentary on the Federal Government's response 
and what we have come to expect as an appropriate response 

4.- !^u^^l^ ¥^°^ ^^^^ ^^^ standpoint that the Government's 
timetable has been simply unacceptable. We count not in months 
or weeks or in days, sir; we count in lives. We count in terms of 
lives that may very well be lost as a result of a lethargic response 
Because of its mysterious nature, and I submit, because of the 
groups associated with it, AIDS has generated something just short 
of a public panic. A good deal of that panic has been fostered by 
homophobes bent on turning a public health crisis into an opportu- 
nity to attack the gay and lesbian community. 

Recently we could not ask for a more forthright response in the 
personal statements of PHS officials like Dr. Brandt, their sincere 
and willing effort to be out front in reassuring the general public 
about unwarrantea concerns of casual contact with persons with 
AlDb and members of high risk groups. Unfortunately, the pro- 
grammatic efforts backing up those statements seem to be very 
weak leaving us open to the calculated abuses that we have wit- 
nessed m this community. 

u '^ jf hysteria created by those ill-intentioned people cannot be 
handled by the limited public health education efforts the Federal 
Government has put into effect; leaving us again very vulnerable. 
Ihe federal AIDS hotline, which started with only three lines and 
now fortunately has added five more, is still capable of handling 
only a fraction of the 10,000 calls that attempt to get through to it 
daily, and none of the calls after 5 p.m. eastern daylight savings 
time, when the hotline is shut down. 

Federal public education efforts such as there are concentrate on 
the general public. That is good. But education about AIDS must 
also reach affected groups, persons with AIDS, and those who work 
m very close contact with persons who are from high-risk groups 
We have heard much about health care workers, about morti- 
cians, police officers, and others who are fearful of close contact 
Most of those fears are unjustified. But it is hard to blame people 
who have not received clear-cut guidelines and concrete informa- 
tion to assure them. The Public Health Service should be taking a 
much stronger, a vitally needed lead role in this area. 

Perhaps the one issue that is most inciting of hysteria has been 
concern about our Nation's blood supply. Let me restate the gay 
community s position on the issue of blood donations. At every pos- 
sible forum, we have urged that those in our community who feel 
they might be at risk to AIDS or feel unwell to refrain from donat- 
ing blood We have felt that that is the responsible position. Recent 
reports about dangerously low blood supplies directly result from 
A T^o .^^®^"^®,",*'^ failure to investigate the transmissibility of 
AIDS through blood, to develop a marker for AIDS in blood, to test 
surrogate markers, or to study the safety of the blood supply and 
giving blood. ^ -^ 

The negative effect of this has been that blood donations seem to 

?,f ^® !t^o".^^^?.^ ^^^^ l^^^s by virtue of the lack of blood supply 
than AIDS itself. ^ •' 



20 



From Secretary Heckler on down, the Health and Human Serv- 
ices Department has of late done an excellent public relations job, 
reassuring the public that there are not risks in giving blood, and 
that the dangers of receiving AIDS from a transfusion are mmimai 
at worst. But where were they, sir, a year ago when this issue tirst 
surfaced and the overreaction could have been addressed? And why 
have they still not done the research needed to garner scientific 
support for that position, a position that the public wants to be as- 
sured about? . , „ 4. ..u f„ 

In another vital area, the particular concerns of groups at risk to 
AIDS are reflected most clearly in the issue of confidentiality, an 
issue I know that is quite controversial and of considerable impor- 
tance to you, Mr. Chairman. . , . , i 

This issue has been used in what we consider to be unscrupulous 
ways, to paint the gay and lesbian community as irresponsible and 
unwilling to cooperate with CDC in the fight against AlDb. 

At the very same time, we see that CDC has failed utterly to rec- 
ognize the most basic patient rights of confidentiality and privacy. 
It is used as an excuse, sir, to deny this committee access to infor- 
mation vital to the legitimate performance of the oversight func- 

I want to state unequivocally our position on confidentiality, and 
to offer some legislative proposals to provide strong and lasting 
protection for the privacy and confidentiality of persons with AlDb. 
When we ask what steps have been taken to protect the confi- 
dentiality of the information CDC has already gathered, we are 
told I have been personally told "Trust us." But trust requires a 
history of credibility, and that is conspicuously lacking. 

Some of the most basic social science research precautions for 
protecting confidentiality have not been observed. 

Now, let me make one statement very clear. No community 
could be more concerned about hearing all the necessary informa- 
tion to find an answer to AIDS. It is our community that is being 
ravaged by this disease. We can and we must legitimately ask 
whether collecting full identification information along with sexual 
histories is an essential ingredient to epidemiological research. 

The National Gay Task Force and LAMDA Legal Defense and 
Education Fund are proposing today that the Congress adopt legis- 
lation to extend to all persons who are part of a federally-funded 
research or surveillance program the same conMentiality protec- 
tion others already have under Federal law. The Drug Abuse Office 
and Treatment Act of 1972, for example, provides that medical 
records may be disclosed "only in accordance with the prior writ- 
ten consent of the patient," except in rare cases. 

Similar language covers alcohol abuse programs. 

We propose that Congress enact legislation extending this protec- 
tion to the privacy of medical surveillance and research documents 
to persons with AIDS, both in Federal agencies and those local ju- 
risdictions receiving Federal funds. 

With such legislation in hand, the concerns of our community 
would be addressed, and another precedent for privacy in patient 
rights would be established. . • j 

Mr Chairman, there is a conclusion that my community is draw- 
ing— and the conclusion is that who is being struck with this dis- 



21 

ease is part of why we haven't found an answer to that disease. We 
live with this condition in our lives every moment. 

It is vital that you, sir, that your committee, that the Congress 
understand basic aspects of our lives. We are part of a society that 
has for the most part treated us as outlaws. We have lived as out- 
laws in our own society. To ask for trust without guidelines, to ask 
that we endure what appears to be an interminable time lapse be- 
tween the identification of a problem and the pursuit of a resolu- 
tion of that problem is asking, too much of this community. 

Thank you. 

Mr. Weiss. Thank you very much. 

[The prepared statement of Ms. Apuzzo follows:] 



22 



hGTF 



National GaV Task Force so FIWi Avenue • New York, ^4ew Vof* 10011 • (212) 741-5800 

' Washington Office: 2335 18«h SL, N.W. • Washington. D.C. 20009 • (202) 332-6483 



TESTIMONY 
VIRGINIA M. APUZZO 
Executive Director 



August 1, 1983 
Subconwittee on Intergovernmental Relations & Human Resources 
U.S. House of Representatives 



Member: Leadership Conference on Civil Rights 



23 



Mr. Chairperson, I want to thank you for calling these hearings today. 
They address an issue critical for millions of Americans. We must give hope 
to those who are worried about Acquired Immune Deficiency Syndrome--hope that 
the government will finally respond adequately to this crisis. 

Mr. Chairperson, what you will learn from today's hearings is startling. 
The federal government's response to the AIDS epidemic has demonstrated that 
the health care system of the wealthiest country in the world is, quite 
simply, not equipped to meet the medical needs of its citizens in an emergency 
or an extended crisis. That should be a source of deep concern to all 
Americans'-not just the 20 million gay and lesbian Americans the National 
Gay Task Force represents. 

Before going into detail, let me point out some of the more shocking 
instances of the federal government conducting business as usual--and thereby 
threatening the well-being of Its citizens. 

• Two years after the federal government, belatedly, recognized that AIDS 
was indeed a public health problem, the National Institutes of Health have 
still not funded research into the et iology--the cause— of AIDS. The first 
research to be funded begins in October I983. This delay is unconscionable. 

It does not take a medical degree to realize that unless you are looking into 
the cause of a disease, you aren't likely to find a cure. The process of 
funding NIH research is generally too slow, too cumbersome, and the mechanism 
for setting priorities is obviously askew. 

• The Centers for Disease Control have been forced to beg, borrow, and 
steal from other vital programs to support their work on AIDS. The medical 
detectives who Secretary Heckler says have adequate funding to do their job 
have shut down their hepatitis control program and cut back on VD control and 
childhood immunization to divert resources to AIDS work that is Inadequate at 
best. Surveillance activities are minimal and not providing the basic Informati 
we need. And support services to local governments are only beginning to 

come forth well into the crisis. 

• We are all painfully aware of the hysteria about AIDS that is sweeping 
many parts of the country. The federal government has responded with public 
education efforts that, while sincere and responsible, were initiated after 
the hysteria struck. And even these efforts are woefully underfunded, and 
lacking in personnel and resources. 

NGTF-1 



24 



y • Perhaps the one issue that has most incited this hysteria has been the 
concern about our nation's blood supply. Unwarranted fears about the safety of 
giving and receiving blood could have been avoided had the government responded 
properly. The Public Health Service has recently done a good job of reassuring 
the public about the blood supply--but it has not initiated basic research 
regarding the safety of blood, and whether screening out high-risk groups is 
indeed necessary. In the meantime, because of diminished supplies, the lives 
of all Americans are being placed in jeopardy. 

• This public health crisis has struck miioritics who have traditionally 
been the victims of officially sanctioned discrimination, and democracy has not 
been applied in the policy-making or decision-making process. Affected groups 
like gays and Haitians have not been part of the process. In the health care 
system generally, patients' needs are not necessarily being addressed — though 
they are the ones with the most at stake. 

• The particular concerns of groups at risk to AIDS are reflected most 
clearly in the issue of conf ident ial i ty--an issue I know is quite controversial 
and of considerable importance to you, Mr. Chairperson. The government agencies 
with which we have been dealing, most particularly the Centers for Disease 
Control, have failed miserably to recognize the most basic rights of patients 
and research subjects: that of confidentiality and privacy. This seeming 
inability to address the issue forthrightly and sensitively has undercut the 
effectiveness of what little epidemiologic research the government is doing — 
because those most affected simply don't trust the government to protect their 
rights. The confidentiality issue can and must be addressed in such a way 

that the rights of patients are protected without compromising larger public 
health needs. 

• The tremendous outpouring of support for voluntary efforts within the 
gay/lesbian community has been in sharp contrast to the federal government's 
response. Existing organizations are expanding their work to include issues 
related to AIDS, and new service groups are being formed to meet the crisis. 

An NGTF survey of voluntary organizations in the gay/lesbian community 
found that in I983, more than $2.5 million has been budgeted, with another 
$6.8 million projected for 198'*. These figures do not include local and 
state government grants to these groups, nor do they include the value of 
millions of volunteer hours that sustain these organizations. 

NGTF-2 



25 



This work is a source of tremendous pride for my community. It is banding 
together as a community should. But we cannot be expected to do the job alone. 
The government must help. It must be part of the solution as well. At the 
federal level there has been no effort to include these voluntary organizations 
in planning and coordinating. The PHS sees fit to hold special briefings for 
science editors, but none for those doing the most important science work 
during this crisis. This administration claims to be committed to rekindling 
the volunteer spirit in America. My community has responded to an unprecedented 
degree. Where is the federal government's recognition of and support for 
these efforts? 

y; • Mr. Chairperson, there is a conclusion we can draw about this government's 
response to medical crises that will make some people very uncomfortable. 
The record on AIDS shows--and I submit would prove the same in other instances- 
that the government's slow response on AIDS is directly related to who is 
affected by this disease as much as what the disease is. The groups most 
affected--gay men, Haitians, IV drug users--are traditionally victims of 
discrimination, often officially sanctioned. And among those who have AIDS, over 
AO percent are persons of color. As the author of the national gay/Iesblan 
rights bill, Mr. Chairperson, you are fully aware of the continuing official and 
unofficial discrimination facing the gay/lesbian community. If one Is black 
and gay, or black and an immigrant who doesn't speak Engllsh--the discrimination 
is even greater. A certain lack of speed In the government's response Is 

apparent, especially in comparison to that for Legionnaire's disease, which 

affected a very different sociological cross-section. The Implications of 
this are shocking, but unavo Idable--and unacceptable. Because they are gay, 

Haitian, or IV drug users, these people's lives are thought to be expendable. 

The lesson to be learned is that If you are part of a minority, don't 

expect the government to respond to your needs without a fight. Institutional 

neglect and resistance are more likely to be the norm. 

A detailed look at the federal government's response to the AIDS crisis 

leads to the unavoidable conclusion that in this Administration, there is a 

sharp contrast between the rhetoric of concern and the reality of response. 

The Administration has been out of touch with the magnitude of this crisis. 

It has been following, not leading, the general public and the affected communities. 

In hearings before Cong. Waxman ' s subcommittee. Dr. Brandt admitted that the 

NGTF-3 



26 



fiscal year ISS^i budget request--wh!ch showed less money for AIDS work at CDC 
than in 1983--was prepared "before we understood in fact how much money it would 
require." That belated recognition is shocking enough from an agency with a 
mandate to protect the public health; what Is inconceivable is that the 
Administration has yet to adjust its fiscal year 1984 request to reflect its 
newfound wisdom. 

More than two years after this medical crisis became generally recognized, 
the Administration still has not presented to the public a comprehensive plan 
of attack. More than two months ago, I wrote Secretary Heckler, asking her 
to set forth just such a plan. She has been unable or unwilling to do so--even 
after declaring AIDS to be the nation's number one health priority. CDC, NIH, 
and other agencies are engaged in detective work that Is uncoordinated and 
unplanned. Without a centrally devised approach to research, public and 
private efforts cannot be coordinated and a clearcut assessment of what needs 
to be done and how much It costs cannot be made. As long as a comprehensive 
plan is not forthcoming, the public will legitimately wonder and worry how 
seriously the Administration is taking this issue. 

An understanding of the magnitude of the AIDS problem is essential to 
developing a policy. The CDC is charged with surveillance which could give 
us some sense of the scope of the epidemic. Yet, after all this time, we 
still don't have accurate statistics on the number of cases, partly because 
CDC's programs suffer from inadequate staffing and insufficient funding. 
Dr. Richard Selig of CDC told USA Today (July 21, 1983) that CDC statistics 
probably represented only one-half of the actual number of AIDS cases. 

In 1981, the same year the AIDS epidemic was beginning to get attention, 
CDC's budget was slashed by 20 percent. It is understandable, therefore, though 
unacceptable, that CDC has had difficulties meeting its responsibilities in 
thi s cr isi s. 

To compensate for insufficient funds, CDC has diverted resources from 
existing programs, thus jeopardizing important medical work in other areas. 
The hepatitis control program has been shut down, and the venereal disease 
control and childhood immunization programs have suffered. These are ongoing 
concerns, not luxuries that can be cut back when a more pressing crisis 
arrives on the scene. 

The problem of diverting resources also arose when the Administration sought 
to reprogram $12 million for AIDS work throughout the Public Health Service, 
rather than seek the supplemental budget preferred by Congress. There is no 

NGTF-I* 



27 



excuse for the United States government, faced with medical emergencies, 

to force choices between groups who need help. The protection of the public 

health should not be a zero sum game. 

Here are some more examples of insufficient resources undermining CDC ' s 
efforts: 

• It was only two months ago that CDC was able to send public health 
advisors to San Francisco, Los Angeles, and Miami to assist with AIDS studies. 
New York City wa5 assigned an advisor just a few months earlier. It had been 
well known for some time that these cities were the most affected. (And the 
CDC still has not provided local jurisdictions with special technical 
assistance in public education as they have with other diseases.) 

• Tracing of cases--gett ing more detailed case histories and medical 
information--is important to the epidemiologic research that may give us clues 
to the source of AIDS. It is our understanding that routine risk groups are 
not being traced; only anomalies are being studied In depth. While that may 
provide reassuring information to quell public hysteria, from an epidemiologic 
standpoint It Is the patterns in high-risk groups that might provide us 

wl th an answer. 

• Epidemiologic work is further hampered by Inconsistencies In reporting 
systems about AIDS. Only a few jurisdictions hav- made AIDS a reportable 
disease. With no consistent national policy to deal with information gathering. 
It will remain Impossible to have accurate statistics on how quickly this 
epidemic is growing. 

The question of accurate reporting and surveillance Inevitably raises 
the issue of confidentiality. This Issue has been used in unscrupulous ways 
to paint the gay/lesbian community as Irresponsible and unwilling to cooperate 
with the CDC In the fight against AIDS. And at the very same time, our 
concerns--whIch have been so studiously rejected by CDC--have been used as 
an excuse to deny this committee access to information vital to the legitimate 
performance of Its oversight function. 

I want to state unequivocally the gay/lesbian community's position on 
confidential I ty--so no one in the CDC or elsewhere can misunderstand just what 
will and won't be acceptable to us--and also to offer some legislative proposals 
to take this issue cut of the hands of bureaucrats and provide some strong 
and lasting protection for the privacy and confidentiality of persons with AIDS. 

NGTF-5 



28 



To understand my community's position on confidentiality, the position of 
the gay/)esbian community in American society must first be understood. The 
gay/lesbian community is a disenfranchised minority. In all but one state and 
the District of Columbia, you can still lose your job simply because you are 
gay or lesbian. In half the states, our expressions of love make us criminals. 
Many jurisdictions deny us the right to raise our children or teach those of 
others. The federal government still bars us from military service and employment 
in key sections of the civil service: it subjects others of us to harassment by 
investigations I.ito our lifestyles. Given this context, you can better understand 
why there is suspicion within our community about any surveillance activity 
that can place our names and sexual orientation together in a government 
computer. Yet, that is what the CDC is blithely asking for. 

When we ask what steps have been taken to protect the confidentiality of the 
information the CDC has already gathered, we are told, "trust us." But to trust 
requires a history of cred ibi 1 i ty--and that Is conspicuously lacking. Some of 
the most basic social science research precautions for protecting confidentiality 
have not been observed . 

Now let's make one thing unmistakably clear: no community could be more 
concerned about gathering all the necessary information to find an answer to 
AIDS. It Is our community that is being ravaged by this disease. But we can 
legitimately ask whether collecting full identification Information along 
wi th sexual histories Is an essential ingredient of epidemiologic research. 

There are two purposes for collecting Identification Information: to avoid 
duplication of case histories and to be able to make follow-up contacts. 
After much discussion within the community, with groups such as the New York 
AIDS Network, Persons with AIDS, and the Lambda Legal Defense and Education 
Fund, the following compromise procedure has been suggested: initials only, 
date of birch, city of residence, mother's maiden name, and attending physician 
should be collected. The statistical odds of all that information being 
identical are quite low. The possibility of follow-up contact is assured 
through the attending physician. And we also avoid the possibility of lists of 
gay men falling into the hands of the wrong people. It should be noted that a 
version of this model is already in use In Washington, D.C. 

With the glaring exception of the CDC, this approach strikes all we have 
dealt with--from public health officers in major cities to medical researchers-- 
as reasonable. Yet, we cannot even get the CDC to sit down with us and negotiate 

NGTF-6 



29 



this matter in a professional way. But the CDC and all others must understand: 
unless and until these concerns about confidentiality are resolved, the accurate 
reporting and epidemiologic research we all desire will be incomplete and 
rnaccurate--because patients and physicians with legitimate fears about how this 
information will be handled will resist cooperating with CDC. 

The procedures outlined above provide a good interim model. But a firmer 
basis of trust ultimately needs to be established. Therefore, the National 
Gay Tasl< Force and Lambda Legal Defense and Edjcaticn Fund are proposing today 
that the Congress adopt legislation to extend to all persons who are part of a 
federally funded research or surveillance program the same confidentiality 
protections others already have under federal law. 

The Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1175), for example, 
provides that medical records may be disclosed "only in accordance with the 
prior written consent of the patient," except in rare emergencies. Similar 
language covers alcohol abuse programs. 

We propose that Congress enact legislation extending this protection of the 
privacy of medical, surveillance, and research documents both in federal agencies 
and those local jurisdictions receiving federal funds. Wi'-h such legislation 
in hand, the concerns of our community would be addressed, and another precedent 
for privacy and patient rights would be established. 

Our concerns for confidentiality, Mr. Chairperson, do not in any way diminish 
our support for the work of this committee and its vital oversight function. 
The sudden concerns of the CDC about confidentiality are a red herring. They 
are an excuse to deny this committee access to CDC files. What we are witnessing 
from CDC is an attempt to stonewal l--and that implies that CDC has something 
to hide. 

In their dealings with the gay/lesbian community, the CDC has been taken 
aback that we--the consumers--mi ght have the audacity to question how they 
carry out their mandate. That mandate, CDC needs to be reminded, comes from 
the Congress and the people. It is for us, not them, to determine what is in 
our best interests. 

Given the performance of CDC during this crisis, oversight by this committee 
Is essential. The concerns expressed by CDC regarding confidentiality might 
be taken more seriously if CDC had been more responsive when we discussed this 
issue in terms of their surveillance work. Further, the fact that names are 
part of any records this committee might be seeking is proof of the CDC's 
failure to protect confidentiality. Names should never have been allowed in 
those documents in the first place. 

NGTF-7 



I 



26-097 O— 83 3 



30 



Now that the names are Included, it is important to be sure that, In 
conducting your investigation, appropriate safeguards are taken. To that 
end, I seel< this committee's commitment to continued work with the gay/lesbian 
community so that guidelines that are workable and acceptable to you and to us 
can be adopted. I am confident that can be achieved. 

The general public, and most certainly the gay/lesbian community, are 
looking impatiently to biomedical researchers to find the answers we so 
desperately seek to this disease. Much of the biomedical research is performed 
and/or funded by the National Institutes of Health. Here, too, poor planning, 
poor procedures and poor funding are undermining efforts. 

Money alone won't find a cause or a cure for AIDS. Research that is funded 
should address the right questions and must be of high quality. But these 
criteria do not necessarily dictate delay. The etiology and the question of 
transmlssibi 1 ity through blood are basic, clearly definable Issues. Yet they 
are just beginning to be addressed. 

Research into the etiology of AIDS will not be funded until October 1983- 
The first Request for Applications (RFA) for work to find an Infectious agent 
in this epidemic was issued in May 1983--again, about two fiscal years after 
AIDS became a clearly recognized threat. 

Similarly, the question of researching transmi ss Ibi 1 i ty of AIDS and finding 
markers for AIDS in the blood supply is still in the future--at least as far 
as government-sponsored research is concerned. (The American Red Cross Is spending 
$200,000 to investigate the relationship of transmission of AIDS to blood 
transfusions . ) 

This is part of a pattern o*" lethargy at NIH that may have bureaucratic 
justifications under normal circumstances but has no place during a crisis. 
AIDS was identified as a disease In I98I. It was not until August 1982 that 
the first RFA was issued by NIH and funds did not begin to flow until May I983-- 
and this under an allegedly expedited process! 

One of the explanations for the delay In issuing grants is the need for 
peer review. We certainly do not want money wasted on unworthy projects. But 
there is no reason why peer review committees cannot meet on an emergency basis 
to deal with an emergency situation. 

Above all, when you look at how NIH is handling the funding of research, what 
is driven home again and again is that we lack the resources to do the job, 
even if you accept the Administration's more limited view of what needs to be 
done. In point of fact, there are now more RFA's out than money appropriated 

NGTF-8 



31 



to fund them. Even the NIH bureaucracy recognizes a greater need than the 
budget cutters at 0MB. 

$9.6 million was appropriated for NIH to dea! with AIDS in fiscal year 1983. 
That is the sum total of federally sponsored basic research on AIDS, States and 
local governments, along with the private sector, are coming close to matching 
.that figure on their own: New York State has appropriated $4.5 million for 
research, the University of California has been given S2.9 million; the Cancer 
Research Institute, for example, is spending S350,000; and gay community-based 
organizations have budgeted about $300,000. This Is to make up for the 
federal government's def i c 1 encies--a very sad commentary on the state of NlH's 
response. 

The NIH should issue a general call for research on AIDS--one that does not 
restrict the approaches to be considered. With sufficient resources clearly 
behind it, such an effort will attract the best scientists in the country. I will 
leave it to those scientists to discuss specific research projects. But let me 
outline some of the basic work thai needs to be done: viral and immunological 
research; study o*^ simian AIDS: monitoring what has been called "prodromal" AIDS; 
monitoring the U.S. armed forces and also blood recipients for incursion of 
AIDS; early diagnosis of AIDS and related treatment; screening tests for blood 
donation ("surrogate markers"); and African swine fever virus tests. 

In order even to begin the long process of systematically Identifying the 
transmissible agent for Al DS--cr i t i cal ly important to developing a cure or 
preventive measure--we first must find an experimental animal species that 
is susceptible to AIDS. This has not yet been accomplished. We must test as 
many different primate species as possible in the hope of finding one which Is 
susceptible. In humans, AIDS Incubates close to two years. If this is true 
in other primates, research will be slow and very costly. 

Rhesus monkeys and chimpanzees, for example, cost about $100 per day to 
house and care for. To Intravenously expose 25 animals in each of six species 
of primates with blood from AIDS patients, and house them for two years, comes 
to $10,950,000. To test just five other body fluids and tissues would bring 
the bill to $65,700,000. By adding routine Intraperitoneal and intramuscular 
exposure, the cost soars to $1 97,000,000--al 1 this just to discover a 
susceptible animal so that real research can begin. 

NGTF-9 



I 



32 



How has NIH tack)ed this basic problem? It is spending $56,000 to determine 
if AIDS can be transmitted to two chimpanzees by infusing the animals with plasma 
from AIDS patients. 

The level of research outlined here seems costly. But is It really... in terms 
of the lives saved... in terms of the knowledge gained... and if those aren't worthy 
enough goals, in terms of money saved on health care costs? At an estimated 
$100,000 per case, we have already spent over $170 million on health care 
costs--and that figure may rise to $4.8 billion by the end of 1985 if AIDS cases 
continue to rise at current rates. 

The public must be reassured that serious research is being done or their 
faith that this epidemic will not get out of hand may evaporate. They must 
see real work and real progress--not announcements of ostensibly new discoveries 
that in fact are not new. Such was the case last month with interleukin-2 , which 
only cured AIDS in six test tubes, but was presented with such fanfare as to 
give perhaps unreasonable hope. Or was the announcement timed to coincide 
with Congressional action on AIDS funding--to give the Congress the Impression 
more money was not needed? 

We have seen a good deal of hysteria on the subject of AIDS--above all on 
the question of blood. Let me restate the gay community's position on the Issue 
of blood donations. At every possible forum available to us, we have urged those 
in our community who feel they might be at risk to AIDS or feel unwell, to 
voluntarily refrain from donating blood. That is the responsible approach and 
the right approach--as we wait for the government to take more definitive steps. 

Recent reports about dangerously low blood supplies in many metropolitan 
areas directly result from the government's failure to investigate the 
transmlssibi 1 I ty of AIDS through the blood, to develop a marker for AIDS In blood, 
to test surrogate markers, or to study the safety of the blood supply and giving 
blood. 

The negative effect this has had on blood donations has endangered more 
lives than the threat of AIDS itself. I fear that soon we are going to hear 
of someone dying during an operation for lack of a transfusion, because of the 
public perception that the blood supply and giving blood are unsafe. 

From Secretary Heckler on down, the Health and Human Services Department has, 
of late, done an excellent public relations job reassuring the public that 
there are not risks In giving blood, and that the dangers of receiving AIDS from 
a transfusion are minimal at worst. But where were they one year ago when 

NGTF-10 



33 



this issue first surfaced and the overreaction could have been prevented? And 
why have they still not done the research needed to garner scientific support 
for their position? 

In the meantime, because we have no markers and no conclusive research on 
blood, attempts are being made to screen all homosexual men from donating blood, 
making gay men as a class unfairly bear the discriminatory effect of the govern- 
ment's Inaction on AIDS--whIle blood supplies continue to drop. 

I have alluded to public hysteria over AIDS In discussing the blood question. 
Far from preventing th's hysteria, early statements by federal officials, 
such as Dr. Anthony Fauci of NIH, who wrote an article implying that casual 
contact could spread the disease, actually helped to Ignite it. AIDS has-- 
because of its mysterious nature and, I repeat, because of the groups associated 
with i t--generated something just short of public panic. A good deal of that 
panic has been fostered by homophobes bent on turning a public health crisis 
into yet another opportunity to attack the gay/lesbian community. 

Whatever the cause, AIDS has resulted In a need for public education that, 
while belated, has been marked recently In the PHS by good will and energetic 
attempts to make ';he best of limited resources. There are really four audiences 
for education efforts, requiring very different approaches: the general public 
with vague fears that are easily calmed; affected or high-risk groups In need 
of more detailed response; persons with AIDS; and those people who work In 
very close contact with high-risk groups who have legitimate concerns that 
must be addressed. 

One could not ask for more In the personal statements of PHS officials 
such as Dr. Brandt. They are sincere and willing to be out front In reassuring 
the public about unwarranted concerns of casual contact with persons with AIDS 
and members of high-risk groups. Unfortunately, the programmatic efforts 
backing up those statements are very weak--so weak that they leave the PHS 
open to charges of tokenism and suggestions that these efforts are designed to 
appease critics rather than confront the problem. 

The centerpiece of the public education effort Is the federal AIDS hotline. 
It is clear from the response--some 10,000 atteTipted calls a day--that this 
is at least trying to meet a need. But the process becomes a sham for the 
public, and an unfair burden on those assigned to work on the hotline, when 
you realize that the hotline started with only three lines and nov/, with an 
additional five, is capable of meeting only a fraction of the demand. Once 
more, despite public relations hype, the government Is not willing to devote 
new resources to the job. 

NGTF-11 



34 



Further, those staffing the hotline have been drawn from other public 
affairs positions. They are not specially trained for this kind of work, they 
are not experts on AIDS, and they have not been sensitized to the special 
concerns of the high-risk groups most likely to call. 

The National Gay Task Force can speak with some expertise about hotlines. 
Since October 1982, we have been operating an AIDS crisTsline. Over 3,600 
people daily have attempted to call us. The volunteers who answer these 
phones have undergone at least 20 hours of training--about the subject matter, 
crisis intervention, and general sensitivity to the special needs of their callers. 
There is no less of a need for such training for the federal hotline. 

The NGTF Crisisline, while available to the general public, does focus on 
the needs of one high-risk group. Federal public education efforts concentrate 
on the concerns of the general public. But it is essential that education about 
AIDS reach the most affected groups in particular. It might not be appropriate 
for the federal government to mount such a campaign, if only because suspicion 
of the government is so high among these groups. But at the least, federal 
funds should be available to assist community-based organizations carrying on 
education programs. 

There is one more group of people for whom education efforts are sorely 
needed and desperately lacking. We have heard much about health care workers, 
morticians, police officers, and others who are fearful of contact with persons 
with AIDS or members of high-risk groups. Most of those fears are unjustified. 
But It is hard to blame people who have not received clear-cut guidelines to 
reassure them about their contacts. This is definitely a government responsibility- 
and the PHS should be taking a stronger lead in this regard. 

The cost of medical care for persons with AIDS is one of the more staggering 
aspects of this crisis. While there are no hard figures available, the 
common estimate Is $100,000 per patient. Many AIDS patients spend long periods 
in the hospital, often In Intensive care units. The cost can skyrocket if 
experimental treatments are used; for example, I nterleukIn-2 treatments are 
estimated to run $125,000 per patient. 

To obtain a sense of how the cost of health care affects patients, and how 
that In turn impedes their recovery, let me quote from a letter published In JAMA 
(July 8, 1983) from a group of physicians at the University of Medicine and 
Dentistry of New Jersey, New Jersey Medical School, Newark: 

NGTF-12 



35 



We find that a large portion of our AIDS population 
is indigent and unable to obtain the requisite out- 
patient care. In an ongoing investigation at our 
institution, many patients studied thus far have 
shown evidence of protein-calorie malnutrition and 
multiple vitamin deficiencies. Once discharged, 
they can neither eat well enough to bolster their 
deficient nutritional state nor afford the many 
drugs required for their multiple infections. 

AIDS has pli'ced, so far, a $170 million burden on our health care system, 

which has fallen disproportionately on cities (through Medicaid and city 

hospitals) and Individuals. The only federal response has been to make persons 

with AIDS eligible for Social Security disability. This move, while positive, 

is only a small step toward dealing with the problem--and it adds to the false 

assumption that persons with AIDS are totally disabled. Many continue to lead 

productive lives for long periods of time... but this does not eliminate their 

medical expenses. 

Mr. Chairperson, we appreciate the leadership you have shown In offering 
legislative solutons to this problem. Your bill to eliminate the waiting 
period before Medicare coverage can be extended to those with AIDS deals with part 
of the problem. And your Public Health Emergency Treatment Fund, which would 
provide up to $60 million for cities and states overwhelmed by the costs of 
caring for patients during a health emergency, will provide some much needed 
relief. In the meantime, the federal government must make certain that all 
possible existing benefits for which they are eligible are extended to persons 
with AIDS. 

The overview I have just presented on the AIDS crisis leads to some important 
general observations. It tells us some things about our nation's health care 
system that are distressing to an outside observer and alarming to any person 
or group In the grips of a health care emergency. 

First, the system simply takes too long to respond to a new crisis. Two 
years to begin research Into the etiology of a disease. Two years to begin 
dealing with threats to the blood supply. A way must be found to gear up, 
to pump up the system faster. Cong. Waxman's Public Health Emergency Act, 
which sets aside S30 million a year to deal with new crises such as AIDS, Is 
an important first step toward making the health care system more responsive, 
but even that must still be appropriated. 

But more is needed. Standard mechanisms must be in place to expedite approval 
procedures for new research. Ways to beef up the staffs and functions of agencies 

NGTF-13 



36 



such as CDC, so that a new crisis will not mean shutting down or impairing work 
in other important areas must be found. 

Above all, the government must learn to plan in a comprehensive and 
systematic manner. The Administration's defense for its poor performance on 
AIDS is often that money alone does not solve problems. We can see that: the 
money currently appropriated is not being spent as effectively as it might 
because there has been no planning. It seems so obvious--but it just hasn't been 
done. No one has convened the best minds in and out of government to determine 
what needs to be done, how much it costs, and how it can all be accomplished. 
Perhaps it is time to create an independent health care planning cotmiission to 
deal with this issue--a blue-ribbon commission comprised of the best medical 
minds as well as health care professionals and consumer representatives, a 
commission that is insulated from bureaucratic interests and in-fighting that can 
tell us as objectively as possible what needs to be done. Then we can hold the 
politicians and bureaucrats responsible for implementing the proposals. 

Another concern we must address is the quality of response offered by 
the government's medical establishment. I do not doubt For one instant the 
dedication of those working for NIH and CDC, but serious questions can and 
must be raised about the quality of work being done at institutions such as NIH. 
As the White House Science Council recently reported, the quality of the work 
at NIH is seriously jeopardized by its inability to attract top-flight medical 
researchers. Government medical service must be made an attractive option for 
the best researchers if there is to be any credibility to our government's 
claim that CDC and NIH are the medical detectives of the world. 

We in America pride ourselves on our democratic system. It should mean 
that we have a fundamental right to participate In decisions that affect our 
lives. But Instead, the medical establishment, hiding behind medical degrees 
and Impressive titles, keeps us out of the decision-making process. This is 
true on an individual basis, as patients' rights to choose are ignored or 
trampled upon during treatment or research at all levels of the health care 
system. And It Is true on a broader basis as a crisis disproportionately affects 
particular groups. This often has social as well as medical Impl Icat Ions--yet 
these groups are only allowed audiences with decisionmakers after several years 
of banging on the door--or when the crisis becomes so great that It Is expedient 
for the powers that be to at least appear to include us In the process. When 

NGTF-14 



37 



one baby needs a liver transplant, the crisis gets presidential attention. 
When 1700 people are fighting for their lives, the Administration often seems 
deaf at the highest levels. 

Another issue that the AIDS crisis has brought home to the gay/lesbian 
community in letters writ large in dollar bills, is the cost of health care in 
the United States. Catastrophic illnesses bring catastrophic costs. Well over 
$170 million has been spent on health care alone for persons with AIDS. For 
patients or consumers, hospitals, and local governments, AIDS is just one more 
example of a need to deal forthrightly and thoroughly with the issues of health 
care costs and the need to provide Insurance for all Americans facing 
catastrophic illnesses. 

Mr. Chairperson, I want to thank you again for holding this hearing. 
It has provided a service to my communi ty-- in airing our specific concerns about 
the federal response to AIDS--and an important service to the general public, all 
of whom are potential consumers in the American health care system. For the 
gay/lesbian community, this crisis has forced us to focus cur attention on 
our nation's medical establishment In ways we vould never have imagined. 

The immediate future does not look bright on the issue of AIDS. We have a 
great deal of suffering and many bat t les--emot ional , medicd, and political-- 
ahead of us. But the gay/lesbian community will emerge stronger from this 
cr i s-i s--stronger because of the greater sense of community and new activism 
that this epidemic has generated. When the AIDS crisis is finally over, we will 
not forget what we have learned about health care in the United States. We will 
use our growing strength to return to the halls of Congress and of the Executive 
Branch again and again until the deficiencies revealed to us over the past 
few years are remedied for all Americans. 

Thank you very much. 



38 

Mr, Weiss. Mr. Endean. 

STATEMENT OF STEPHEN R. ENDEAN, EXECUTIVE DIRECTOR, 
GAY RIGHTS NATIONAL LOBBY 

Mr. Endean. Good morning, Mr. Chairman, members of the sub- 
committee. 

My name is Stephen Endean. I am the executive director of the 
Gay Rights National Lobby. As you know, Mr. Chairman, Gay 
Rights National Lobby is the only full-time lobby at Congress on 
gay issues and, until recently, our primary focus has been on insur- 
ing civil rights and equal justice for gay and lesbian Americans. 
But increasingly our focus has necessarily turned to the AIDS 
crisis. We appreciate your invitation for us to join you this morn- 
ing. 

It would be an extreme understatement to say that this Nation's 
gay community, which numbers over 22 million Americans, is not 
deeply concerned about the AIDS crisis. The gay community is 
alarmed by both the slow and insufficient response of the Federal 
Government. In the last 3 years, not only gay men but Haitians, 
hemophiliacs, women and children have come down with the syn- 
drome. People are dying from a disease which medical science 
knows almost nothing about. 

Secretary Heckler has named AIDS the number one public 
health priority. Dr. William Foege, the director of the Centers for 
Disease Control, has said "AIDS is the most complex epidemic 
we've ever had to deal with." But while the press and the public 
have heard that this crisis is the No. 1 priority, it appears that the 
administration has failed to communicate a similar message to its 
budget offices or to the Appropriations Committees. 

Quite frankly, the Federal Government's response to the AIDS 
crisis thus far remains a cruel joke. Since fiscal year 1981, when 
AIDS was first identified as an epidemic, the National Institutes of 
Health, which is the largest medical research organization in the 
world, has spent only $12 million on AIDS research to date. And 
yet NIH has spent $11.2 billion on other medical research since 
fiscal year 1981. In other words, only one-tenth of 1 percent of the 
NIH research budget has been spent on AIDS. Whether the reason, 
or excuse, is the inherent bureaucratic delays in responding to 
public health emergencies or it is another example of a far too 
common institutional homophobia by the Federal Government, the 
response to date by the Federal Government has been inexcusable. 

By contrast. State and local governments, which normally do not 
even fund significant medical research which has traditionally 
been a Federal responsibility, have committed about $8 million to 
AIDS research this year, almost as much as the Federal Govern- 
ment estimates it will spend on basic AIDS research in 1983. 

Recently, both Houses of Congress overwhelmingly voted to in- 
clude $12 million for AIDS research in the 1983 supplemental ap- 
propriations bill. That $12 million would nearly double Federal 
funding for AIDS research. Shortly the bill will go to President 
Reagan and, unfortunately, he has threatened to veto it. We sin- 
cerely hope he does not, because even with the additional $12 mil- 



39 

lion, researchers will only be able to begin the massive effort neces- 
sary to discover the cause of AIDS and how it can be stopped. 

A moment ago, I alluded to not only too little but too late. It is 
shocking that it has taken 3 years for the Federal Government to 
begin to take action, shocking in view of the mortality rate, shock- 
ing in view of the media attention the AIDS crisis has received, 
shocking in view of not only the deep concern but near hysteria of 
the American public. 

Gay Rights National Lobby congratulates the Congress for the 
decision to create a public health emergency research fund to more 
expeditiously disburse Federal research dollars to combat public 
health crises such as AIDS. Representative Waxman, Senators 
Kennedy and Cranston, and others who worked to establish this 
fund certainly deserve our thanks. 

It is important to remember that AIDS is the only infectious dis- 
ease which can attack and destroy the body's immune system. Be- 
cause of this unique characteristic, scientists believe that if they 
conquer AIDS, they will better understand the immune system. 
Top medical experts consider AIDS one of the great research chal- 
lenges and opportunities in medical history. 

But of course AIDS is more than just a research opportunity, es- 
pecially to the more than 1,200 Americans who have the disease. 
No one with AIDS has lived longer than 3 years after being diag- 
nosed, and no one has recovered from the underlying syndrome. 
Five to six new cases are reported every day, and the total number 
of cases doubles every 6 months. 

Unfortunately, having a critical illness is only part of the burden 
persons with AIDS must carry. The ignorance and discrimination 
they face is incredible. I applaud you, Mr. Chairman, for including 
in these hearings persons with AIDS themselves. No one could pre- 
sume to speak for them or share their experiences so eloquently. 

One area of concern is the staggering medical bills that persons 
with AIDS must face. Many are forced to give up all their property 
and rely on medicaid and public hospitals to provide the highly 
complex and usually experimental treatment they need. Medicaid 
and public hospitals simply cannot provide this care. 

Congressman Weiss, we applaud you for introducing a bill last 
week that would provide $60 million for treatment and prevention 
activities required to combat public health emergencies such as 
AIDS. The Congress simply must address the medical care needs of 
persons with AIDS, and other victims of epidemics. 

Your bill is particularly significant in that it addresses not only 
the medical care problems caused by AIDS, but also the public 
health and prevention problems, which have become critical. Hys- 
teria is rampant. People are combining their fear of the disease, 
their homophobia and their racism, and using that combination to 
justify bigotry and discrimination against gays and against Hai- 
tians. They are punishing persons with AIDS by firing them from 
their jobs, by denying them housing, by denying them fundamental 
human rights. 

And what has our Federal Government done to quell this hyste- 
ria and stop the backlash? Far too little. 

Thus far no money has been budgeted or appropriated for public 
education on the AIDS epidemic. HHS has prepared a one-page 



40 

factsheet on AIDS, which is available if you call the national AIDS 
hotline. But good luck. It's estimated that 50 percent of the callers 
who attempt to get through on this hotline don't. If one gets 
through, one can't expect highly trained experts on the subject to 
answer questions. Public relations employees with no medical or 
public health training give standard replies. 

While we can take some consolation that Secretary Heckler and 
the administration have not embraced Reverend Falwell's un- 
christian views of the AIDS crisis, views that are little more than 
justifications for bigotry and discrimination toward gay people, 
HHS education efforts thus far remain woefully inadequate. A real 
and substantive education program, not media hype, is needed. 

The appropriations process for fiscal year 1984 is now underway. 
While no figures are yet available from the Appropriations Sub- 
committee, we are deeply concerned that none of the figures specu- 
lated about approach the real need. Not only the administration 
but the Congress, that is charged with representing all the people, 
people who live in great fear of AIDS, must face the fact that funds 
must be increased dramatically and immediately. 

The Gay Rights National Lobby, in cooperation with the newly 
created AIDS Federation, with the National Gay Task Force, and 
with others both gay and nongay, has pledged to continue to active- 
ly advocate such dramatically increased Federal funds for research, 
patient care, and education on the AIDS crisis. However, it re- 
mains more than a little ironic that lobbying initiatives are even 
necessary in the face of such a serious crisis and statements that it 
is the No. 1 public health priority. 

Mr. Chairman, let nothing that I have said here today be miscon- 
strued to make light of the considerable efforts and real concern of 
many Members of Congress. Without those efforts, much of what 
has been done probably would not have been. But Federal efforts to 
this point remain too little, too late, and too much business as 
usual. 

Mr. Chairman, members of the subcommittee, I congratulate you 
on your hearings and ongoing oversight efforts. I hope they will 
assist this Congress in getting to a more effective and expeditious 
response to this public health crisis. 

I believe that Representative Waxman, who has worked on 
health policy for many years and most effectively, is correct when 
he said, "There is no doubt in my mind that if the same disease 
had appeared among Americans of Norwegian descent, or among 
tennis players rather than among gay males, the response of both 
the government and the medical community would have been dif- 
ferent." 

Thank you, Mr. Chairman and members of the subcommittee, for 
the opportunity to discuss this matter today. 

Mr. Weiss. Thank you for your testimony. 

Dr. Compas. 



41 

STATEMENT OF DR. JEAN-CLAUDE COMPAS, VICE PRESIDENT, 
HAITIAN MEDICAL ASSOCIATION ABROAD 

Dr. CoMPAS. Thank you, Mr. Chairman. Thank you, members of 
the committee, to invite the Haitian groups to come here and 
speak about the question of AIDS. 

In the United States, where the incidences of AIDS and its fatali- 
ty rate have been m.ost impressive, scientists began investigating 
the disease more than 3 years ago. However, causative factors and 
mechanisms of transmission have not yet been definitively deter- 
mined. Despite the lack of a conclusive scientific data base and, as 
Haitian AIDS patients have repeatedly and persistently denied any 
history of homosexuality, drug abuse or hemophilia, U.S. health 
authorities declared Haitians a high-risk group. 

In an effort to rationalize this arbitrary classification, several 
theories have emerged. At the outset, it was suggested that AIDS 
might have originated in Haiti as a result of the voodoo practices. 
It was then suggested that Haitians may be genetically predisposed 
to the disease. As neither of these hypotheses could be scientifically 
substantiated, the so-called Haitian connection was more recently 
explained by establishing a liaison between the African swine 
fever, which had struck Haiti in 1978, and the deadly new syn- 
drome, through the alleged consumption of undercooked pork by 
Haitians, followed by homosexual relations between Haitian male 
prostitutes and homosexual American tourists — Newsweek, May 
16, 1983. The latest one states that there must be some tropical fac- 
tors in the Haitian connection. 

The most elementary analysis of these theories indicates that 
there was a great deal of unfounded speculation by the CDC and 
other U.S. AIDS-related groups. To date, no epidemiologic survey 
has ever been conducted among the Haitian population in the 
United States. Most of the data used by the CDC and other health 
authorities were gathered by hospital-based physicians with no 
knowledge of French or Haitian Creole and who, in addition, have 
admitted to a complete ignorance of the intricacies of Haitian cul- 
ture. 

Sociologists have established that diseases such as tuberculosis, 
syphilis, epilepsy, and behaviors such as homosexuality and drug 
abuse are strongly stigmatized and taboo in highly religious and 
non-Western societies such as Haiti. No Haitian should therefore 
be expected to ever admit, let alone confess to a stranger, having 
had at any time engaged in these so-called deviant practices. 

In addition, most of the Haitian AIDS victims are uneducated, do 
not speak English or French and, having no legal status in the 
United States, live in constant fear of being deported. The credibil- 
ity of their responses to any American interviewer should certainly 
be considered questionable, at best. 

In an attempt to investigate the African swine fever connection, 
the serum of Haitian AIDS patients in Haiti was tested for the 
presence of antibodies to African swine fever virus — The Lancet, 
July 9, 1983, page 110. These antibodies were not detected. 

Haitian physicians investigating in Haiti and in the United 
States, though working with far less sophisticated technical facili- 
ties and more modest financial means than researchers from the 



42 

CDC, have established that more than 30 percent of the Haitian 
AIDS population have actually admitted to homosexual experience. 
This points to the necessity of utilizing Haitian personnel in re- 
search activities. 

As a result of their separate classification, a Haitian phobia rap- 
idly developed in U.S. communities. Haitians across the country 
were being evicted from their jobs. 

Children were not spared. Haitian pupils were harassed by their 
schoolmates. Mothers forbade their children to play with Haitian 
children. In an elementary public school in Brooklyn, a teacher re- 
fused to resume her classroom activities, stating that there were 
too many Haitians on the premises. 

THE MEDICAL ENVIRONMENT 

Haitian AIDS victims are mostly recent undocumented immi- 
grants without any legal status. In the hospital, they suffer the 
same discriminatory treatment as other AIDS patients. However, 
upon discharge from those facilities, they face additional insults. 
They are not eligible for social services or any type of public assist- 
ance such as medicaid. Even the victims who are legal immigrants 
are newcomers to the country and are therefore unaware of availa- 
ble resources. 

HAITIANS' RESPONSE TO AIDS 

Since the beginning of this ordeal, Haitian communities across 
the country have set up special AIDS task forces. In New York, for 
example, we have organized a scientific committee for research 
purposes and have founded, in cooperation with the community, 
the Haitian Coalition on AIDS. Immunologic studies which we 
have performed in collaboration with Downstate Medical Center 
have demonstrated that there is no immunodeficiency in the Hai- 
tian population. 

From a sociological perspective, we have had to deal with three 
major problems. These include the growing fear and frustration of 
the Haitian community, the detrimental relations between the Hai- 
tian community and its neighbors and the social problems encoun- 
tered by the victims of AIDS. 

In most communities, the Haitian Coalition on AIDS has done its 
best to overcome these three problems. We have employed a multi- 
media approach in attempting to educate the population. We have 
been faced with the necessity of sheltering some of the victims; we 
have had to provide food and money to buy their expensive medica- 
tions. We must see to it that they are educated so that they can 
understand what is being told to them in the hospitals. We must 
also provide some form of counseling for relatives and close friends 
whose confusion and frustrations are multiplied because of the lan- 
guage barrier. All of these activities are being carried out without 
the help of any local or Federal agencies. 

Regarding relations with the American community, we think 
that at this stage it is imperative to inform Americans that Hai- 
tians were erroneously classified as a high-risk group. As of July 
28, 1983, New York City no longer lists Haitians as a high-risk 
group. 



43 

We appreciate Dr. David Sencer's courageous and scientific 
stand. However, it is not enough that categorization remain in the 
Federal list. The CDC argue that the total Haitian case is very 
high compared to the Haitian population here, 103-to-l million — 
but what if we were to designate their 1922 cases according to na- 
tional origins. Let us ponder about this statement. 

While we are aware that the CDC is currently launching an epi- 
demiologic study of the Haitian community, we emphasize that it 
will not be valid unless it utilizes professionals and questionnaires 
adequately adopted to our Haitian culture. 

On the social front, we must develop a program to repair the 
damage caused by this unscientific classification of Haitians by the 
CDC. To accomplish this vast task, we will need cooperation by the 
various public health authorities and the media as well as substan- 
tial resources. We need educational and counseling programs; we 
need halfway houses for our patients. In addition, we need to devel- 
op some type of financial relief for victims of AIDS which will 
apply to all victims, regardless of their immigration status. 

Again, our resources are severely limited. As recent immigrants 
in this country, we do not have the connections or the means to 
make our voices heard. Even if we do succeed in telling the truth, 
the public, we will still have to deal with the subtle, yet malignant, 
fear that people carry within themselves when they are faced with 
ignorance and misinformation. 

We deeply appreciate the opportunity you have given us to 
present our case before this subcommittee. We have all gratefully 
received the moral support of various community groups and politi- 
cians. This support has been vital to us and to our efforts. Unfortu- 
nately, the support which we have received falls far short of our 
necessities. The task before us is of tremendous magnitude and will 
require substantial Federal funding. We urge you to consider our 
plight and to act accordingly. 

Thank you. 

[The prepared statement of Dr. Compas follows:] 



44 

Prepared Statement of Dr. Jean-Claude Compas, Vice President, Haitian Medi- 
cal Association Abroad, New York Chapter, Chairman, Haitian Coaution on 
AIDS 

DflRCOUCnON 

As is well known, the disease narf identified as the Acquired Imnuno-Deficiency 
Syndrome, or AIDS seems to have erupted simultaneously in ncre than 17 countries 
throughout the world during the past four years. In four of these countries, 
nanely, the Zaire and the Congo in Africa, and the United States and Haiti in the 
Western Hemisphere, it has taken, in the past twelve itonths, the form and the 
virulence of an epidemic. 

In the Lhited States, where the incidence of AIDS and its fatality rate have 
been irost iitpressive, scientists, including specialists in imnunology and epide- 
miology began investigating the disease more than three years ago. However, 
causative factors and mechanisms of transmission have not yet been definitively 
determined. Despite the lack of conclusive sciencific data base, a high-risk 
group categorization was established by the Center for Disease Control (CDC) in 
late 1982 based solely upon the incidence of the disease in the New York area. 
As a resiilr, three social/medical groups, homosexuals, intravenous drug abusers 
and hemophiliacs, and one ethno-national community, Haitian immigrants, were 
labelled as being responsible for the eruption and the spread of the AIDS outbreak. 
For the first time in history, a disease was being attributed to a nationality 
without clear epidemiologic or scientific justification. 



THE FACTS 

In 1981, a few Haitians residing in the United States were diagnosed with 
Pneumocystis Carinii Pneumonia - a lung infection caused by a parasite - and 
Kaposi's Sarcoma - a rare form of tumor or cancer of the blood vessel walls; 
two infections that were identified as being most caranonly associated with 
the AIDS syndrome. During the same period, the same pathological conditions 
were diagnosed in much greater numbers among homosexuals, intravenous drug 
abusers and hemophiliacs. 



-1- 



45 



In 1983, the number of AIDS victims in the United States rose to 1552, and the 
social profile of the disease displayed the following pattern according to a July 
27, CDC report: 



CASES 



Homosexuals or Bisexuals 


71.3% 


1901 


IV Drug Abusers 


17.1 


266 


Haitians 


5.0 


101 


Hanophiliacs 


0.8 


13 


Unknown 


5.8 


90 



As Haitian AIDS patients have repeatedly and persistently denied any history 
of hoiosexuality, drug abuse or hemophilia. United States health authorities, for 
statisticcil purposes, declared them a separate high-risk group. 

In an effort to rationalize this arbitrary classific ation, three theories 
have CTierged. At the outset, it was suggested that AIDS might have originated in 
Haiti as a result of tlie Voodoo practices. It was then suggested that Haitians may 
be genetically predisposed to the disease. As neither of these hypotheses could 
be scientifically substantiated, the so-called Haitian connection was more recently 
explained by establishing a liaison between the African Swine Fever - which had 
struck Haiti in 1978 - and the deadly new syndrome, through the alleged consunption 
of undercooked pork by Haitians followed by homosexual relations between Haitian 
male prostitutes and homosexual American tourists (Newsweek, May 16, 1983) . 

The most elementary analysis of these theories indicates that there was a great 
deal of unfounded speculation by the CDC and other U.S. AIDS-related groups. 

To date, no epidaniologic survey has ever been conducted among the Haitian 
population in the United States. Most of the data used by the CDC and other health 
authorities were gathered by hospital-based physicians with no knowledge of French 
or Haitian Creole and v*io, in addition, have admitted a ccatplete ignorance of the 
intracacies of Haitian culture. Sociologists have established that diseases such 
as tuberculosis, syphilis, epilepsy, and behaviors such as homosexuality and drug 
abuse are strongly stigmatized in highly religious and non-western societies such 
as Haiti. Those Haitians who have been victimized by AIDS have originated primarily 



26-097 0—83- 



46 



fron the lower socioeconamic strata vAiere such practices are particularly taboo. 
No Haitian should therefore be expected to ever admit, let alone confess to a 
stranger, having had at any time engaged in these 'deviant practices. 

In addition, nost of the Haitian AIDS victims are uneducated, do not speak English 
or French and, having no legal statxas in the U.S. live in constant fear of being 
deported. The credibility of their responses to any American interviewer should 
certainly be considered questionable at best. 

Furthentore, the Haitian diaspora is not limited to the U.S. Approximately one-third 
of the population of the Bahamas is coiposed of Haitians. There are sane 300,000 
Haitians in the Dotiinican Republic, 15-20,000 in French Guyana and 8-10,000 in the 
French Antilles. Yet, no occurrence of AIDS has been reported in these territories. 

On the other hand, Haitian physicians investigating in Haiti and their colleagues 
of the Haitian Doctors Association (AMHE) operating in the U.S., though working with 
far less sophisticated technical facilities and more modest financial means than 
researchers from the CDC, have established that more than 30% of the Haitian AIDS 
population have actually admitted to a honosexual experience. 

In an attanpt to investigate the African Swine Fever connection, the serum of Haitian 
AIDS patients in Haiti was tested for the presence of antibodies to African Swine 
Fever (ASFV) by inmunoelectro-osmophoresis and by indirect iimiuno-fluorescence (The 
Lancet, July 9, 1983, p. 110). These antibodies were not detected. Investigations 
on necropsy or biopsy materials were also unsuccessful (ibid, loc) . 



THE SOCIAL ENVXEO^MENT 

As a result of their separate high-risk classification, other high-risk groups began 
to use the Haitians as scapegoats, blaming their miseries on the imaginary Haitian 
connection. The media also capitalized on the issue. As a spawned population, 
because of their intnigrant and low socioeconcmic status, Haitians had no access to 
U.S. itedia. It was simple to turn the anger of an already panicking population 
against black, poor, illegal iitmigrants . A New York magazine correctly noted that 
every Haitian had become an object of dread. 



47 



A Haitian phobia rapidly developed in U.S. cotinunities . As a result, Haitians across 
the country were being evicted frcm their jobs. Restaurants, hotels and parking areas 
were firing their Haitian personnel. Haitian hare attendants and housekeepers were 
ejected frcm their employment. In one particular instance, a Haitian maid presented 
herself to work on a Monday morning, only to find all of her belongings in the street 
and to be told through a closed door that as all Haitians were sick she would not 
receive her salary directly but by mail. Haitian applicants were advised by Heme 
Services Agencies not to reveal their Haitian identity if they wanted to be accepted 
by the clients. The New York Times, Channel ABC and other prominent media confirmed 
these horror stories. 

Children were not spared. Haitian pupils were harrassed by their schoolmates. Nksthers 
forbade their children to play with Haitian children. In an eleitentary public 
school in Brooklyn, a teacher refused to resume her classroan activities stating 
that their were too many Haitians on the premises. In seme apartnent houses, leaf- 
lets were circulated urging parents not to let their children mingle for any purpose 
with their Haitian counterparts. 



THE MEDICAL ENVIPONMENT 

Haitian patients have been receiving minimal care in hospitals because of fear of 
j*iysical contact by health care workers and professionals. The incidence of psycho- 
somatic diseases such as headaahes, acute ulcers, impotence, generalized itching and 
stress related diseases such as hypertension have been increasing in the Haitian 
catmunity. The pride and self-esteem of the Haitian population has also been 
damaged iinneasurably. The management of this crisis by the American Public Health 
Ccnimmity has made it extremely difficult and painful for most Haitians to admit 
their identity. 

Haitian AIDS victims are mostly recent undocumented immigrants without any legal 
status. In the hospital, they suffer the same discriminatory treatment as other AIDS 
patients. However, upon discharge from those facilities, they face additional 
insults. Many of them, being recent immigrants, have no families. Others are rejected 
by their families and friends. They have no place to live and cannot find rooms. 
They are not eligible for social services such as Medicaid. Even the victims who 
are legal irtmigrants are newccroers to the country and are therefore unaware of 



48 



available resources. Ihe stress experienced by these AIDS victims upon release 
frxan the hospital could contribute to the higher mortality rate suffered among the 
Haitian AIDS population. 



HAITIAN RESPOSISE TO AIDS 

Since the beginning of this ordeal, every substantially sized Haitian conmunity 
across the country has set up special AIDS Task Forces. In New York, for example, 
we have organized a scientific cartitdttee for research purposes and have founded, 
in cooperation with the ccmnLinity, a Haitian Coalition on AIDS. Inmunologic studies 
which we have performed in collaboration with Downstate Medical Center have demon- 
strated by randcsn blood sampling fron the Haitian popiiLation, that there is no 
iimiunodeficiency in the Haitian population at large, nor is there a tendency among 
Haitians to develop AIDS. 

We have been debating with the CDC the potential for an extensive epidemiologic 
study vdiich would investigate all centers of heavy Haitian intnigration . We have 
stipulated in our discussions that Haitian scientists and professionals should be 
involved in these studies. So far, no official answer has been received. 

On the social aspect of the AIDS issue 've have had to deal with three major 
problems. These include the growing fear and frustration of the Haitian camunity, 
the detrimental relations between the Haitian contiunity and its neighbors and 
the social problems encountered by the victims of AIDS. 

In most coninunities, the Haitian Cocilition on AIDS has done its best to overccroe 
these three problems. We have employed a multimedia approach in attempting to 
educate the population. However, our efforts are hampered by severe financial 
constraints. 

No study has yet been done to evaluate the long term effect of the AIDS propaganda 
on the Haitian camunity. We have established an information hotline and have 
tried to provide counseling for the families of the victims. 

Regarding relations with the Alter ican cotttnunity, we think that at this stage, it is 
necessary to tell the public the truth about the transmissibility of the disease and 
to inform Anericans that Haitians were erroneously classified as a high-risk group. 

-5- 



49 



Again, our resources are very limited. As recent iirmigrants in this country, we do 
not have the connecticins or the means to make our voices heard. Even if we do succeed 
in telling the truth to the public, we will still have to deal with the subtle fear 
that people carry within themselves v^en they are faced with ignorance and misinforma- 
tion. 

We have been faced with the necessity of sheltering some of the victims as well as 
their families. We have had to provide food and money to buy their expensive 
medications. As already mentioned, many of these patients are undocunented aliens 
and have been denied social benefits. We must see to it that they are educated so 
that they can understand v*at is being told to them in the hospitals. We must also 
provide seme form of counseling for relatives and close friends vdiose confusion and 
frustrations are multiplied because of the language barrier. All of these activities 
have been and are being carried out v.i.thout the help of any local or federal agencies. 

Vfe deeply appreciate the opportimity you have given us to present our case before 
this Subccnmittee. We warmly thank Congressman Major Owens for his help in the 
Brooklyn area. We have all gratefully received the moral support of groups such 
as the National Council of Churches, 1199 and DC37, the Bedford Stuyvesant Family 
Health Center and Downstate Medical Center. This support has been vital to us. 
Unfortunately, the support vAiich we have received falls far short of our necessities. 



OUR NEEDS 

On the scientific front, an adequate epidemiologic stu(^ including proper interviewers 
and questionnaires adequately adapted to our Haitian culture should be the priority. 
We do kno^.' that the CDC is launching such a study. However, we enphasize that in 
order to be successful, it must use professionals v\,tio are familiar with the Haitian 
culture. The study will not be valid otherwise. In addition, we need a broader 
spectrum of irtitiunologic research studies. 

On the social front, we must develop a program to repair the damage caused by this 
unscientific classification of Haitians by the CDC. We need programs to educate 
our people as well as the American conmunity and to do counseling for the family 
manbers of the victims. We need halfway houses for the patients with no housing in 
order to alleviate their suffering and prevent the dissemination of AIDS. The task 
is indeed of tremendous magnitude and requires substantial federal funding. . 



89 



-6- 



50 
Mr. Weiss. Mr. Brownstein. 

STATEMENT OF ALAN P. BROWNSTEIN, EXECUTUVE DIRECTOR, 
NATIONAL HEMOPHILIA FOUNDATION 

Mr. Brownstein. Thank you very much. 

The National Hemophiha Foundation is most grateful for the 
support that Congress has provided over the years for much needed 
hemophilia research and care. This support has facilitated a revo- 
lution in hemophilia treatment over the last 10 years. 

Plasma clotting factor concentrates have become widely available 
and home infusion therapy has freed these patients from hospital 
care and emergency room visits. 

The committee report accompanying the Omnibus Budget Recon- 
ciliation Act of 1981 concluded, "Hemophilia treatment is one of 
the biomedical and medical successes of the decade." This state- 
ment is based on clear-cut documentation of progress in hemophilia 
treatment. And I ask you to consider the following 1981 data as 
compared with 1975. 

The number of patients on home care has nearly quadrupled. 
Hospital utilization is down, more than 80 percent; average hospi- 
tal days per year reduced from 9.4 to 1.8. The percent of unem- 
ployed adults dropped from 36 percent to 12.8 percent. These im- 
portant human benefits are coupled with significant economic sav- 
ings. Careful studies have documented a 62-percent reduction in 
total health costs per patient for the 9,500 hemophiliacs enrolled in 
Federal subsidized comprehensive care centers. This is down from 
$15,800 in 1975 to $5,932 per person in 1981. 

Clearly the advances in hemophilia care have enabled hemophili- 
acs for the first time in history to lead nearly normal full and pro- 
ductive lives. 

Now we are faced with the frightening specter of AIDS. Al- 
though in absolute terms the number of hemophiliacs, 16, who 
have become afflicted with AIDS may seem small, the risk of con- 
tracting AIDS is far greater among hemophiliacs than any other 
risk group. Today, of the 20,000 hemophiliacs, one out of 1,250 has 
contracted AIDS. 

Further, if you consider that there are approximately 7,500 he- 
mophiliacs who are classified as severe, that is those who are far 
more dependent upon blood products, the risk is much greater, one 
out of every 500 hemophiliacs. It is indeed ironic that the very sub- 
stance that has served to liberate hemophiliacs from the disabling 
aspects of their disease is now highly suspect as the source of 
AIDS. 

The fear of AIDS among hemophiliacs has been exacerbated by 
extensive and in some instances distorted reporting by the media. 
Some patients have abandoned appropriate use of blood products 
because they fear contracting AIDS. This is documented by report- 
ed reductions in blood clotting factor sales. These are reports from 
industry as well as from treatment centers that are reporting re- 
duced use of the much needed clotting factor. 

This is an inappropriate response and the foundation is now 
making major efforts to urge hemophiliacs to maintain use of the 
clotting factor in the treatment of hemorrhagic episodes. 



51 

The risk of not treating exceeds the risk of contracting AIDS, be- 
cause uncontrolled bleeding is the leading cause of death among 
hemophiliacs, not to mention the potential of serious orthopedic 
complications and crippling if bleeding episodes are untreated. 

The fear of AIDS has other tragic implications. No longer are flu 
symptoms or fever passed off as trivial problems. Some family 
members have questioned whether physicial closeness with hemo- 
philic children may be dangerous. Similarly, sexual partners 
wonder whether intercourse should be avoided. Many physicians 
and treatment centers are deluged with calls from apprehensive 
patients and families seeking information, and of course reassur- 
ance. Many patients are fearful that their treatment may be 
changed. And this is a threat to the autonomy they have gained 
through home therapy. And this represents a potential of being set 
back two decades to the old sense of helplessness and dependence 
upon others. 

As you can see, the incidence of AIDS among hemophliacs is of 
serious concern. But of even greater concern is the profound 
impact of the threat of AIDS. 

We are most grateful for the support of Congress and the Federal 
agencies involved with AIDS. All of the Federal agencies involved 
with AIDS and hemophilia have worked closely with the National 
Hemophilia Foundation during this difficult period. 

CDC has kept us informed of all new cases and hemophilia-relat- 
ed developments in a timely way so we have ample time to commu- 
nicate to treatment centers, chapters, and patients throughout the 
country. This has helped a great deal to reduce undue alarm that 
results from misunderstanding of media reports about the disease. 
The CDC has involved the input of our medical expertise and is 
working in collaboration with the foundation on two major studies. 

The NIH as well has worked closely with the foundation and has 
relied heavily upon the input of our medical experts. In response to 
the urgency of AIDS, NHLBI has provided increased funding sup- 
port for AIDS research and has successfully compressed the peer 
review process without sacrificing quality in order to get new re- 
search activity moving as quickly as possible. 

For example, a study of blood product use in genetic and immu- 
nologic factors that may contribute to the development of AIDS was 
approved in a very short time. This is also true of two other impor- 
tant studies that are just getting off the ground that will begin in 
early 1984, which is much shorter than the usual review process. 

One of the problems regarding research, according to our medi- 
cal advisers, is related to the very complexities of the disease itself. 
Because of the many unknowns, it has been difficult for the scien- 
tific community to develop a well-focused research strategy which 
is needed. 

Last January the National Hemophilia Foundation's Medical and 
Scientific Advisory Council issued a series of recommendations. 
These recommendations included urging that those who might 
transmit AIDS should be excluded from blood donation. And here 
again the Public Health Service, with the involvement of CDC and 
the Food and Drug Administration, used a series of recommenda- 
tions directed at discouraging blood donation from high-risk 
groups. 



52 

Last, the Office of Maternal and Child Health, which has respon- 
sibility for the Federal Hemophilia Treatment Center program, has 
been supportive of all of our efforts concerning AIDS. 

In summary, we are pleased with the support, sensitivity, and 
sense of urgency demonstrated by the various branches of the 
Public Health Service. 

But the needs that have been created by the AIDS crisis in our 
view will require much more Federal support in the years ahead. 
The National Hemophilia Foundation considers research in this 
area to be a matter of highest priority. We urge you to give this 
problem your most serious consideration. 

Adequate funding should be provided to the CDC to expand its 
epidemiologic investigation and laboratory studies of AIDS, and 
major increase in allocations to the NIH are needed to study the 
etiology of AIDS. 

Basic research is fundamental in helping us to learn more about 
this disease. In addition, the special urgency represented by AIDS 
requires specific funding support. The recently-enacted Public 
Health Emergency Research Act should be fully funded at the $30 
million level, so that funding will be available as new develop- 
ments unfold with AIDS. 

The AIDS crisis has created a need for comprehensive care for 
hemophiliacs that is greater than ever before. An informal sam- 
pling revealed a 25-35 percent increase in patient encounters at 
many comprehensive centers throughout the country due to AIDS. 
Physicians and nurses are seeing patients more frequently as pa- 
tients are being examined and tested for AIDS type symptoms. Pa- 
tients require more education concerning their risks and fears as 
well as the treatment of actual AIDS cases. This increased demand 
for care is most difficult because most of these treatment centers 
are operating on a shoestring budget as it is. 

We urge an additional $2 million of new funding to be ear- 
marked for the Hemophilia Treatment Center program for a total 
of $4.6 million for fiscal 1984. This additional funding is essential 
to the increase in new AIDS-induced demand for services. 

Because there is so much misunderstanding about AIDS and he- 
mophilia, it is important that funding be provided to expand the 
flow of accurate information to physicians and patients throughout 
the country in order to improve patient care and to coordinate he- 
mophilia-related research activity. Currently, the National Henio- 
philia Foundation is partially addressing this need through its 
scarce resources and we would be supportive of any government 
initiative in this area. 

In closing, I would like to express our appreciation to this com- 
mittee for the focus you are providing on this disease. We need 
your help to respond to this new and devastating problem. 

The recognition that AIDS appears to be transmitted through 
clothing factor concentrates has had a profound effect on the hemo- 
philiacs and their families. Indeed, AIDS is a cloud over the entire 
hemophiliac community. 

I thank you for providing us with the opportunity to share our 
views with you today. Thank you very much. 

[The prepared statement of Mr. Brownstein follows:] 



53 




"nHENAnONAL 
HBADPHIUA FOUNDAnON 



TESTIMO'JY SUBMITTED TO THE HOUSE OF REPRESENTATIVES 
INTERGOVERNMENTAL RELATIONS AND HUMAN RESOURCES SUBCOMMITTEE 

OF THE 
COMMITTEE ON GOVERNMENTAL OPERATIONS 



HEMOPHILIA AND ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS): THE FEDERAL RESPONSE 



Statemefit by: The National Hemophilia Foundation 

Alan P. Brownsteiii, M.P.H., M.S.W. 

Executive Director 

The National Hemophilia Foundation 

August 1, 1983 



19 WEST 34th STREET • SUITE 1204 • NEW YORK, NEW YORK 10OO1 • (212) 563-0211 



54 



I am Alan P. Brownstein, the Executive Director of The National Hemophilia Foundation. The National 
Hemophilia Foundation is made up of 48 chapters tiroughout the country and is the only national organization 
in the United States that is exclusively devoted to Improving the health and welfare of the 20,000 persons with 
hemophilia and other related bleeding disorders. (Attached to the testimony is a brochure that briefly 
describes hemophilia and the work of the Foun Jation.) 

The Foundation is most grateful for the support that Congress has provided over the years for much needed 
hemophilia research and care. As you are aware, this support has facilitated a revolution In hemophilia 
treatment over the last ten years. Plasma clotting factor concentrates have become widely available and home 
infusion therapy has freed these patients from hos lital care and emergency room visits. The Committee report 
accompanying the Budget Omnibus Reconciliati )n Act of 1981 (H.R.3982) concluded ". . . hemophilia 
treatment is one of the biomedical and medical success stories of the decade." This statement is based on clear 
cut documentation of progress in hemophilia trea:ment over the past eight years. I ask you to consider the 
following 1981 data as compared with 1975: 

- the number of patients receiving comprehensive care increased more than 350%; 

- the number of patients on home care nearly quadrupled; 

- hospital utilization is down more than 80% (average hospital days per year reduced from 9.4 to 1.8); 

- the percent of unemployed adults droppec from 36% to 12.8%; and 

- there has been a 75% reduction in the number of days lost from work or school each year. 

These important human benefits are coupled «ith significant economic savings - careful studies have 
documented a 62% reduction in total health cost p( r patient ($1 5,800 per year in 1975; $5,932 per year in 1981) 
for the 9,500 hemophiliacs enrolled in federally subsidized comprehensive care centers. 

Clearly, the advances in hemophilia care (i.e., aval ability of AHF concentrates, comprehensive care and home 
therapy) have enabled hemophiliacs, for the firsi time in history, to lead nearly normal, full and productive 
lives - a truly dramatic turnaround from the early 1970's. 

The Impact of AIDS 

Now we are faced with the frightening specter of AIDS as it has appeared in the hemophilia population. 
Although in absolute terms the number of hemophiliacs (16) who have become afflicted with AIDS may seem 
small, the risk of contracting AIDS is far greater imong hemophiliacs than any other risk group. Today, of the 
20,000 hemophiliacs, one out of 1,250 has contracted AIDS. Further, if you consider that there are 
approximately 7,500 hemophiliacs who are classif ed as severe, who are far more dependent on blood clotting 
products, the risk is much greater - 1 in 500. It is indeed ironic that the very substance that has served to 
liberate hemophiliacs from the disabling aspects of their disease is now highly suspect as the source of AIDS 
infection. To those with hemopilia, AIDS repreS'Snts the makings of a nightmare - a lethal threat from a 
mysterious source. Blood clotting factor replacenent, the source of their newly found freedom from pain and 
disability, has changed overnight from a life sust.iining substance to a possible threat to their survival. The 
progress of two decades suddenly became a "mixed blessing". 

The fear of AIDS among hemophiliacs has been exacerbated by extensive and in some instances distorted 
reporting by the media. In many respects excess fear of AIDS among some hemophiliacs has presented more 
risk of death and disability than AIDS itself. Some patients have abandoned appropriate use of blood products 
because they fear contracting AIDS. This is l>ased on anecdotal reports from patients and physicians, 
particularly orthopedists, who have reported increased joint damage resulting from Inadequately treated 
bleeding episodes. This concern is further documented by reported reductions in blood clotting factor sales 
from industry and reduced blood clotting factor use from treatment centers. This is an inappropriate response 
and the Foundation is now making major efforts to urge hemophiliacs to maintain use of clotting factor in the 



55 



treatment of hemorrhagic episodes. The risks of not treating exceed the risks of contracting AIDS because 
uncontrolled bleeding is the leading cause of death among hemophiliacs not to mention the potential of serious 
orthopedic complications if bleeding episodes are untreated. 

The fear of AIDS has other tragic implications. No longer are flu symptoms or fever passed off as trivial 
problems. Some family members have questioned whether physical closeness with their hemophilic children may 
be dangerous. Similarly, sexual partners wonder whether intercourse should be avoided. How sad it was the 
other oay when I learned from one of our chapters that their hemophilia camp enrollment was down 75% this 
year because parents of hemophilic children had fear of their children being exposed to other children with 

hemophilia. We are now beginning to get reports of instances in the workplace where fear of cor trading AIDS 
Is expressed by those working side by side with hemophiliacs. 

Many physicians and treatment centers are deluged with calls from apprehensive patients and f imilies seeking 
information and, of course, reassurance. A number of physicians themselves are concerned an<l disagreement 
exists among experts as to whether or not treatment should be modified. Some have suggssted that the 
potential for reducing the risk of AIDS would be increased If cryopreclpitate, which is derived from smaller 
donor pools was used instead of the dominant replacement therapy now in use - AHF concentmtes which are 
derived from much larger donor pools. Yet, there is serious question raised as to whether or not this would 
represent a safer alternative and, of course, the patients are caught in between as the unc«rtainty among 
physicians compounds the distress. Many patients are fearful that their treatment may b,. changed - a 
perceived threat to autonomy gained from home therapy and the potential of being set back two decades to the 
old sense of helplessness and dependence upon others. 

As you can see, the Incidence of AIDS among hemophiliacs is of serious concern, but of even gre iter concern Is 
the profound impact of the threat of AIDS for all hemophiliacs throughout the country. Because It Is suspected 
that this dreadful disease Is caused by a transmissible agent that can be spread through blood products we urge 
that the public sector continue and expand its efforts to learn more about the spread and etiology of this 

The Federal Response to AIDS: Current 

We are most grateful for the support of Congress and the federal agencies Involved with AIDS. All of the 
federal agencies Involved with AIDS and hemophilia have worked closely with The Natior.al Hemophilia 
Foundation during this difficult period. 

The Centers For Disease Control (CDC) has kept us Informed of all new AIDS cases and hemDphllia related 
developments. They have been sensitive to the needs of our constituents by providing background Information 
in a timely way so that we have ample time to communicate to treatment centers, chapters anc patients. This 
has enabled us to establish the Foundation as the major source of information for the hemophilia community. 
I his has helped a great deal to reduce undue alarm that results from misunderstanding of medis. reports about 
the disease. The CDC has served as an always available source of information which has heloed t d control many 
unfounded rumours (and there have been many). The CDC has heavily involved the input of our medical 
expertise and is working in collaboration with the Foundation on two major studies. 

The National Institutes of Health (NIH) as well has worked closely with the Foundation and has relied heavily 
upon the input of our medical experts. 

In response to the urgency of AIDS, the National Heart. Lung and Blood Institute (NHLBIj has provided 
Increased funding support for AIDS research and has successfully compressed the peer review process, without 
sacrificing quality, in order to get new research activity moving as quickly as possible. For exan.pie, a study of 
blood product use and genetic and Immunologic factors that may contribute to the development of AIDS was 
approved (pending final determination of funds needed) In a short time. 

NHUBl has also Issued an RFA on July 15 to develop new tests for determining the AIDS carrier state. And, at 
this time, an RFP is being prepared for a prospective epidemiologic study on hemophilia and other diseases 
requiring blood product use. It is expected that both of these studies will be operational within seven months of 



56 



issuance of :he RFA/RFP. We are impressed with this responsiveness because, as you know, the peer review 
process usuj lly talces much longer. It is clear to us the NHLBI has been active in generating ideas as well as 
committing resources to seeking new scientific thinking. 

One of the problems regarding research, according to our medical advisors, is directly related to the 
complexitic! of this disease. Because of the many unknowns, it has been difficult for the scientific community 
to develop a well focused research strategy. 

Last January, The National Hemophilia Foundation's Medical and Scientific Advisory Council issued a series of 
recommend; tions (full text of January 14, 1983 recommendations attached) to prevent AIDS in patients with 
hemophilia. One of those recommendations urged as a precautionary measure that those who might transmit 
AIDS shoulc be excluded from blood donation. The Public Health Service (PHS), with the involvement of CDC 
and the Food and Drug Administration (FDA) issued a series of recommendations directed at discouraging 
blood donation from high risk groups. And, most recently, the FDA's Office of Biologies held a meeting on July 
19 to discuss the safety and purity of plasma products with specific attention directed at recall of plasma 
derivatives n situations where a donor is identified as an AIDS patient or has symptoms of AIDS. There was 
agreement ibout having ongoing discussion concerning newly reported cases of suspect donors. 

And lastly, the Office of Maternal and Child Health (OMCH), which has responsibility for the federal 
hemophilia treatment center program, has been supportive of all of our efforts concerning AIDS. OMCH was 
very helpful in assisting us in our collaborative survey with CDC of all treatment centers in the nation. Further, 
efforts are being made to identify resources to bring treatment center directors together in the Fall to discuss 
AIDS and its impact on treatment. 

In summary, we are pleased with the support, sensitivity and sense of urgency demonstrated by the various 
branches of the PHS. 

The Federal Response to AIDS: Future 

Yhe needs that have been created by the AIDS crisis, in our view, will require more federal support in the years 

ahead. Because hemophiliacs require blood products for their very survival and because these blood products 

have the po .ential for AIDS, the hemophiliac has a special interest in efforts to understand and control this 

disease. 

A. Researi :h - The National Hemophilia Foundation considers research in this area to be a matter of highest 
priority and we urge you to give this problem your most serious consideration: 

- adequiite funding should be provided to the CDC to expand its epidemiologic investigation and laboratory 
studiei of AIDS; and 

- major increases in allocations to the NIH are needed to study the etiology of AIDS. 

In recent years, NIH funding has not kept pace with inflation. Basic research is fundamental in helping us to 
learn more about this disease. In addition, the special urgency represented by AIDS requires specific funding 
support. Th« recent enactment of the Public Health Emergency Research Act (H.R.2713) provides up to $30 
million for tie purposes of having the financial reserve capacity to address public health emergencies such as 
AIDS. We ur ge that appropriations be made at the $30 million level, so that funding will be available as new 
research direction is defined for AIDS. We also urge that efforts continue to review research proposals as 
rapidly as possible without undermining the quality of the peer review process. 

B. Treatment Center Funding - The AIDS crisis has created a need for comprehensive care that is greater 
than ever before. An informal sampling has revealed a 25% to 35% increase in patient encounters at many 
comprehensive care centers and this is specifically du« to concern about AIDS. Physicians and nurses are 
seeing patieits much more frequently as patients are being more carefully examined and tested for AIDS type 
symptoms; patients require more education concerning the risks and their fears; as well as treatment of actual 
AIDS cases. This increased demand for care is most difficult because most of these treatment centers are 



57 



©periling on a shoestring budget after being cut bacic 22% last year. 

We urge an additional $2 million of new funding to be earmarked for the hemophilia treatment center program 
for a total of $4.6 million for fiscal year 1984. This additional funding is essential if we are to adequately 
address this new AlDS-lnduced need for services for those who are currently enrolled in comprehensive care 
centers. Thrs would also provide a modest expansion of comprehensive care to those states that are not 
currently part of the federal treatment center network. 

£. Patient and Provider Education- Because there is so much misunderstanding about AIDS and hemophilia 
t is important that funding be provided to expand the flow of accurate information to physicians and patients 
throughout the country in order to improve patient care and to coordinate research activity. Such an 
information network would also serve to collect hemophilia specific AIDS related data, survey and disseminate 
information concerning product use and new forns of treatment. Currently, The National Hemophilia 
Foundation is partially addressing this need through its scare resources. The National Hemophilia Foundation 
would be supportive to any government initiative in tills area. Active<li$cussion is currently underway with the 
OMCH for potential funding in this area. 



In closing, I would like to express our appreciation to this Committee for the focus you are providing on this 
disease. We need your help to respond to this new and potentially devastating problem. 

The recognition that AIDS appears to be transmitted through clotting factor concentrates has had a profound 
effect on hemophiliacs and their families throughout the country. AIDS is a cloud over the entire hemophilia 
community. 

Thank you for providing us with the opportunity to share our views with you today. 
August 1, 1983 



58 




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Recommendations of 
the Medical and Scientific 
Advisory Council submitted 
to ttie NHF Board of Directors 



THENAnONAL 
HB/KDPHIUA FOUNDAnON 



THE NATIONAL HEMOPHILIA FOUNDATION 

MEDICAL AND SCIENTIFIC ADVISORY COUNCIL 

January 14, 1983 

RECOMMENDATIONS TO PREVENT AIDS IN PATIENTS W ITH HEMOPHILIA 

L Recommendations for physicians treating patients with hemophilia. 

A. It is recommended that cryoprecipitate be used to treat patients in the foUowing 
groups except when there is an overriding medical mdieation: 

newborn infants and children under 4; ,„ .. » 

newly identified patients never treated with factor vm concentrate; 
patients with cUnically mild hemophUia who require infrequent treatment. 
Similar guidelines should be appUed to factor IX deficiency patients where fresh 
frozen plasma can be used instead of concentrate. 
B The potential advantages and disadvantages of cryoprecipitate versus factor VE 
concentrate therapy for severe hemophUia A are not clear at the present time ana 
are controversial. The Medical and Scientific Advisory Council does not offer a 
specific recommendation at this time, but will continue to review the data. 

C. DDAVP shoiUd be used whenever possible in patients with mUd or moderate 
hemophilia A. 

D. AU elective surgical procedures should be evaluated with respect to the possible 
advantages or disadvantages of a delay. 

n. Recommendations to factor Vm concentrate manufacturers: 

A. Serious efforts should be made to exclude donors that might transmit AIDS. These 
should include: 

1 Identification, by direct questioning, individuals who belong to groups at high 
risk of transmitting AIDS, specifically male homosexuals; mtravenous drug 
users; and those who have recently resided in Haiti. 

2. Evaluation and implementation (if verified) of surrogate laboratory tests that 
would identify individuals at high risk of AIDS transmission. 

3 In addition, the manufacturers should cease using plasma obtained from donor 
centers that draw from population groups in which there is a significant AIDS 
incidence. It is clear from the epidemiologic data that the pool of mdividuals 
at risk for AIDS transmission is not uniform throughout the country and that a 
great deal could be achieved by excluding donors from the "hot spots". 
B Efforts should be continued to expedite the development of processing methods 

that will inactivate viruses potentially present in factor vm concentrates. 



! WEST 34th STREET • SUITE 1204 » NEW YORK. NEW YORK 10001 • (212) 563-0211 



61 



C. There should be an evaluation of the possibility that iJiij yield of factor VIII in 
pheresis donors could be increased using DDAVP or ercercijo co rrax;nize yield. 
This would permit a reduction in the si^e cf tl.e uor.or pool nrd voiu'c" compensate 
for losses in plasma that might occur due to iteps re ted ioovs. 

D. There should be an evaluation of the feasibility of fractionating and processing 
plasma so that lyophilized small pool products are available. While this will 
certainly be more costly, it may be the only way to break out of the present 
dilemma without going to an all-cryoprecipitate effort. 

E. Concentrate manufacturers should immediately cease purchase of recovered 
plasma for factor VIH concentrate from blood centers that do not meet the criteria 
listed in n A above. These criteria should also apply to the production of 
cryoprecipitate. 

F. Manufacturers should accelerate efforts towards the production of coagulation 
factor concentrates by recombinant DNA technology. 

in. Recommendations to regional and community blood centers: 

A. Those centers that are in regions in which there is a very low incidence of AIDS 
should increase capacity for cryoprecipitate production to be used locally and in 
other regions. 

B. These centers should evaluate the feasibility of preparing small pool lyophilized 
cryoprecipitate for hemophilia treatment. 

C. The production of cryoprecipitate should also adhere to criteria detailed in HA, 
above. 



26-097 0-83 5 



62 




THE NATIONAL 
HBOPHIUA i=OUNDA"nON 



HEMO PHILIA AND ACQUIRED IMMUSE DEFICIENCY SYNDROME (AIDS) 

■ FACT :;heet 

FEDERAL SUPPORT NEEDS 



- FULL FUNDING FOR EPIDKMIOLOGIC INVESTIGATION AND 
LABORATORIES STUDIES (CDC); 

- FULL FUNDING FOR BASIC BIOMEDICAL RESEARCH, AIDS- 
SPECIFIC FUNDING AND $30I<11LLION APPROPRIATION FOR THE 
PUBLIC HEALTH EMERGENCY ACT (NIH); 

- $4.6 MILLION ($2 MILLION NEW FUNDING) TO SUPPORT 
HEMOPHILIA TREATMENT C:ENTER PROGRAM TO MEET THE 
INCREASED DEMAND FOR SERVICES DUE TO AIDS (OMCH); AND 

- FUNDING FOR PATIENT AND PROVIDER EDUCATION RELATED 
TO AIDS. 

I. HEMOPHILIA - WHAT IT IS - Hemophilia is a lifelong, hereditary blood clotting disorder which affects 
males almost exclusively. Hemophiliacs' blood does not clot due to the inactivity of a plasma protein ,n their 
blood. Hemophiliacs may experience uncontrolled, painful bleeding and hemorrhaging. Chronic joint bleeding 
results in progressive joint damage and crippling without adequate treatment. 

II. INCIDENC E OF AIDS - Sixteen cases of AIDS confirmed, nine deceased. This represents a rate of one 
out of 1,250 hemophiliacs with AIDS. Among hemophilics who are classified as severe, the rate is one ,n 500. 

Ill IMPACT OF AIDS - Since the early 1970's, the advances in hemophilia care have enabled hemophiliacs, 
for the first time in history, to lead nearly normal, full ind productive lives. Now this population is faced with 
the frightening specter of AIDS. Blood clotting factor replacement, the source of their newly found freedom 
from pain and disability, has changed overnight from 2 life sustaining substance to a possible threat to their 
survival. The fear of AIDS has tragic implications. Some hemophiliacs have abandoned use of blood products 
even though the risks of not treating exceed the risks oV contracting AIDS because unconrolled bleeding is the 
leading cause of death among hemophiliacs, which ii compounded by the potential of serious orthopedic 
implications if bleeding episodes are not treated. 

IV. RESEARCH HEMOPHI LIA, AND AIDS - Bec»jse hemophiliacs depend upon a factor derived from 
blood plasma, they are vulnerable to anything that may contaminate blood products. More research ana 
epidemiologic work needs to be done to reduce the spread of Al DS and, in the long run, to reduce other risks of 
blood infectivity in the future. Such research will benefit the general public as well as hemophiliacs. 

V. HEMOPHILIA TRE ATMENT AND AIDS - Due to AIDS, the need for comprehensive care is greater than 
ever before. Physic i ans a nd nurses are seeing patients much more frequently and the need for psychosocial 
Intervention has greatly increased. 

Vi. PATIENT/PROVIDER EDUCATION AND AIDS - Because there is so much misunderstanding about 
AIDS and hemophilia, it is important that funding be piovided to expand the flow of accurate information to 
physicians and patients. 

August, 1983 

19 WEST 34th STREET • SUITE 1204 • NEW YORK, NEW YORK 10001 • (212) 563-0211 . 



63 

Mr. Weiss. I want to thank all of you for your testimony. It has 
been very effective, eloquent, and factual. 

I also want to thank each of you for summarizing and highlight- 
ing your testimony. Your prepared statements will all be entered 
into the record. I hope that not only members of this committee, 
but Members of the House and the general public will take occa- 
sion to read those full statements because they are filled with a 
wealth of factual information and analysis that go far beyond the 
summaries which we asked you to make in the interests of saving 
time. 

We will again adhere to the 5-minute rule and go around as 
many times as is necessary to cover all the questions that members 
have. 

Ms. Apuzzo, in the course of your testimony you stressed, as did 
some of the witnesses prior to your testimony, the issue of confi- 
dentiality. And as you may know, for some 8 to 10 weeks this sub- 
committee has been attempting to get access to factual information 
from the Centers for Disease Control and other component agencies 
of HHS. HHS has repeatedly raised the issue of confidentiality, 
claiming they were not confident that the subcommittee would 
adhere to the requirements of confidentiality. 

We have taken great pains, as I said in my opening statement, to 
assure and reassure the Department that, in fact, we had no inter- 
est in learning the names of people afflicted with AIDS. They were 
not necessary for our oversight work. Indeed the last thing that we 
did was to provide a detailed system for CDC to excise whatever 
names may be in those files and to assure that our people would 
never get to see them. 

We still have not gotten access to the files, incidentally. 

I give you all that background because I really had not known 
until I read your testimony the extent to which CDC has been 
using the other side of the argument in refusing to recognize the 
concerns that the community at risk, which you represent, had 
about questions of confidentiality. 

I find that to be the height of cynicism; in the one instance to be 
using the confidentiality argument to obstruct the work of their 
oversight subcommittee and, at the same time, to refuse to recog- 
nize the legitimate confidentiality concern which you have ex- 
pressed. 

Would you go into some greater detail as to what efforts you 
have made to work out the confidentiality issue with CDC? 

Ms. Apuzzo. Yes, Mr. Chairman. 

It is necesary to provide you with some sense of what our com- 
munities are dealing with in their various locales. In New York, 
early on confidentiality became an issue of enormous concern to us, 
an issue relating to the blood question, and in the context of epi- 
demiology. 

We have attempted in our own networks to raise the conscious- 
ness of our community about the necessity of being as cooperative 
as possible in reaching a resolution of AIDS. But again and again, 
as Mr. Callen pointed out, the community has had to acknowledge 
that there was no premise, no substance, no basis upon which to 
provide information to a government that in fact denies us job se- 
curity — in 24 States we are illegal, sir — denies us the opportunity 



i 



64 

to serve in the military, denies us the opportunity to raise our own 
children, denies us an opportunity to teach other people's children. 

You must understand the reality of our lives. When that Govern- 
ment — CDC, NIH, any other Government institution — comes to us, 
asks us questions that in fact represent illegalities in I believe 24 
States — you must understand that it is not paranoia. It is the very 
real fear of our lives that has raised our concerns here. 

We have worked in locales and then had an opportunity in 
Denver to come together at a gay lesbian health conference, where 
I chaired a public policy seminar. At that particular seminar, we 
had paradigms, constructions, that we had worked out with 
Lambda legal defense to demonstrate that we would be willing to 
provide all the information essential, providing confidentiality 
would be assured, that providing that CDC and Government would 
enter into an agreement to assure us that in fact this information 
would not be used to sabotage our lives in the future. 

We have not been able to get to first base in our negotiating with 
CDC to utilize this kind of a system. And so it is only as a last 
resort that we come requesting that legislation be considered that 
would guarantee not only thoroughness in that vital area of epi- 
demiology, but the security needed so that persons could respond to 
questions and could guarantee integrity about that data that we so 
desperately need. That has been just a bit of our experience. 

Mr. Weiss. Thank you very much. 

Dr. Compas, in the course of your ter.timony, you indicated that 
in New York City the Department of Health has now removed Hai- 
tians as a special category of communities or groups at risk. You 
have indicated that has not yet happened with CDC at the national 
level. 

Have you engaged in any discussions or are there discussions on- 
going regarding CDC following through on a similar kind of deter- 
mination? 

Dr. Compas. Yes. In fact, we have started to discuss with CDC 
more than a year ago. Two or three weeks ago we have met with 
Dr. Joyce Johnson, who is supposed to be the chief epidemiologist 
for epidemiological research in the Haitian community. We told 
her what we consider as a weakness in those studies upon which 
the classification is done. 

What we have found is that, as I have said in my testimony, 
most of the patients were interviewed by Americans, who don't 
know the Haitian culture, don't speak Creole, don't speak French 
at all. Those patients are undocumented, what they call "illegal 
aliens." 

They came to their bed, asking questions like: are you homosex- 
ual, drug addicts, all things that are supposed to be illegal. The 
answer was always no. What we have told the CDC is that the in- 
terviewers should be Haitians, people who do understand the cul- 
ture of the patients and who can communicate properly with the 
patients. 

In New York City, Dr. Sencer understood what we have told him, 
he is a very scientific man. On the basis of what we have found in 
New York, he decided to remove the Haitians from the high-risk 
group. The CDC, in their article in the New York Times yesterday, 



65 

said that they are not going to remove the Haitians on their list, 
and also they are not going to use any Haitian interviewers. 

In fact, somebody said, Dr. Fishee I think from Miami, she said 
she doesn't believe that Haitians should interview Haitians, which 
is in our opinion totally unscientific. If you are dealing with people 
who are in a different catergory, have a different culture, you have 
to use agents who know this culture. 

I feel in the gay community here, the people who are interview- 
ers were Americans, they share the same culture as the gay com- 
munity, they have some differences — but basically the cultural 
background is the same. And we do feel it should be the same for 
Haitians. 

Mr. Weiss. Thank you very much. 

Mr. Walker? 

Mr. Walker. Thank you, Mr Chairman. 

Ms. Apuzzo, I understand from the chairman now that your writ- 
ten record, your written remarks have been submitted for the 
record. 

Ms. Apuzzo. Yes, sir. 

Mr. Walker. And I assume, then, that questions about those 
written remarks are in order as well as what you delivered. 

Ms. Apuzzo. To the best of my ability I will attempt to, sir. 

Mr. Walker. Fine, thank you. 

On page 3, you make the allegation or the suggestion that dis- 
crimination, either racial or otherwise, is being pursued against 
people with AIDS. And you suggest rather vividly that someone in 
the Government thinks that AIDS victims are expendable. 

Those charges are pretty sensational, and they are pretty seri- 
ous. What I would ask you, since they are on the record, is if you 
could provide us with the names of any Government officials who 
you think are guilty of such acts, and if you could give specific inci- 
dents that have led you to make such serious allegations. 

Ms. Apuzzo. Yes, sir. 

Let me say that I will provide you with additional data. But let 
me say this, sir: In the last year the blood issue, as we have heard 
from our representative from the hemophilia community, this last 
year the gay community and other communities, the Haitian com- 
munity, have been essentially standing out there on a limb where 
the blood issue has been concerned. 

If you will, sir, it was 1 year ago, that Dr. Curran came to New 
York and identified the blood issue as a very volatile issue. 

There is no need to demonstrate to you, I think, the amount of 
stigmatization associated with the term "gay blood, bad blood." I 
think it pretty much speaks for itself. 

In that year, we have headline after headline after headline that 
suggested that the blood supply in this country was being contami- 
nated by homosexuals. The homosexual community has responded 
with what I consider to be unprecedented force and unprecedented 
commitment, to educate itself, educate itself long before the media 
took up the question of AIDS. 

If you look back at the publications in this community over the 
last 2 to 3 years, you will find that each publication, many of which 
are circulated free of charge, have made every attempt to bring to 
the gay community the latest information, attempting to get the 



66 

gay community politicized, to be able to apply pressure, and beyond 
that, in light of this blood crisis, attempting to demonstrate to our 
community a responsible response to what was being told to us. 

In that 12-month period, sir, we have been left hanging out on a 
limb. 

Increasingly, headlines have alleged that we were simply looking 
to be obstreperous or failing to cooperate with a life and death situ- 
ation. 

I maintain, sir, that the lethargy with which the Federal Govern- 
ment has responded has made many of us victims of redtape, as we 
heard earlier. 

That kind of vulnerability to a community that is already vul- 
nerable, has resulted in outbreaks of violence against gay people, 
which I can document and give you names. 

I don't know the facts about how much research is actually going 
on, despite the fact that I have asked for it consistently. I don't 
know today what programs are going on where. 

I have information to the fact that in this 1-year period, despite 
the fact that Dr. Curran came to us a year ago and identified the 
volatile issue of blood, there is now $56,000 in one program seeking 
to find a resolution of the blood issue, which has left us very vul- 
nerable. 

Mr. Walker. I thank you, and I hope you will provide us for the 
record with the specific incidents to which you refer. 

If I understand, though, in your testimony, I did not hear the 
names of any Government officials specified here. You were evi- 
dently indicating or expressing the attitude that AIDS victims are 
expendable. 

There are such Government officials? 

Ms. Apuzzo. Sir, when a government fails to respond to an issue 
that is resulting in the loss of life, it is convenient not to be able to 
find a single individual. 

It is convenient to blame it on a system, but that system, in fact, 
has been something less than just lethargic in responding to our 
need, something less than just lethargic to responding to our cry 
for assistance, and what I would consider to be an attempt to co- 
operate. This community has approached the Government consist- 
ently, attempting to cooperate and be a part of the process with the 
Government. Rarely has that offer been accepted. 

Mr. Walker. I was going to ask you to go beyond the systemic 
problem and identify the specifics. 

Ms. Apuzzo. I think, sir, when fully 6 months ago I asked Dr. 
Curran, in the company of representatives from the Lambda Legal 
Defense, over the telephone, for a report that would demonstrate to 
us exactly what programs were in effect, what their costs were, 
what professional personnel were assigned, and what the clerical 
support were for each of those programs, and I did not get an 
answer; and 2 months later I wrote a letter to Dr. Brandt; 2 
months ago, I wrote to Secretary Heckler and still do not have an 
answer. That is a 6-months' lag, and if we don't know what the 
Government is actually doing, how can we responsibly know what 
it is to ask for? 

Mr. Walker. You mentioned on three occasions. Dr. Curran. Are 
you accusing Dr. Curran of engaging in racial or other 



67 

Ms. Apuzzo. The issue has to do with the fact that the victims of 
AIDS, 40 percent of the victims of AIDS, are people of color. 

The longer the situation is allowed to persist, the more vulner- 
able the population is. 

Mr. Walker. OK. I am trying to get to some specifics here, 
though. 

Are you accusing Dr. Curran of engaging in discrimination or in 
treating the problem as though AIDS victims are expendable? 

Ms. Apuzzo. I am accusing the entire system, sir, of failing to re- 
spond with the same speed and the same commitment that might 
have been its motivation, if those persons who were vulnerable to 
AIDS were, in fact, a member of another sociological group. 

Mr. Weiss. If the gentleman will allow, 7 minutes have elapsed. 
We will come back for a second round. 

Mrs. Boxer? 

Mrs. Boxer. Mr. Brownstein, do you feel that there should be a 
way to develop a test so we can tell from a blood sample if it car- 
ries AIDS disease? 

Mr. Brownstein. Absolutely; yes. We have supported that as 
being the best way of preventing AIDS until we learn more about 
how this disease is spread, and what it is; there should be some 
sort of a test. 

Mrs. Boxer. Do you know at this time whether such research is 
going on in the Federal Government? 

Mr. Brownstein. Yes, it is. The Centers for Disease Control is 
exploring different types of tests, and also an RFA has been issued 
by NHLBI to determine, to learn more about the AIDS carrier 
state, and should be operational at the beginning of 1984, and hope- 
fully this will provide new information about what kind of testing 
should be applied to the blood. 

Mrs. Boxer. What does the Government, if you know this, spend 
on research on hemophilia? 

Mr. Brownstein. OK. 

Mrs. Boxer. What did it spend in the height of the research 
effort? 

Mr. Brownstein. I cannot answer that specifically. One of the 
problems is that there are so many areas that are related to hemo- 
philia; much of genetic research is related to hemophilia, as is 
much of the research related to joint diseases, and so on; so it is 
difficult to pinpoint a specific number, but we do receive printouts 
from the various Institutes of the NIH, so that the Foundation and 
its medical research advisory group can keep tabs on what is going 
on in different places, and I would be glad to share that informa- 
tion with you after this hearing. 

Mrs. Boxer. You can't give me a ballpark figure as to how much 
research money is spent specifically through the Hemophilia Foun- 
dation, so we can try to get a handle on that kind of information? 

Mr. Brownstein. Specifically, through The National Hemophilia 
Foundation, there is about $100,000 of research. 

NHF is a small foundation. That is private nongovernmental 
funds supplemented by about $30,000 of Government funds. 

Mrs. Boxer. So you feel, I would assume, above and beyond that, 
we would need to put more funds into the testing of blood to pick 
up the AIDS disease? 



68 

Mr. Brownstein. Absolutely. 

Mrs. Boxer. Have you quantified how many dollars it would take 
just on that research effort alone? Any ideas on that? 

Mr. Brownstein. No, but we can furnish that information to this 
committee, should it be desirable. 

Mrs. Boxer. I would appreciate that. 

[The information follows:] 



69 




THE NATIONAL 
HEMOPHILIA FOUNDATION 



September 7, 1 983 



Honorable Barbara Boxer 

U.S. House of Representatives 

1517 Longworth House Office Building 

Washington, DC 20515 

Dear Ms. Boxer: 



I am most pleased with the interest you have taken concerning the serious 
matter of Acquired Immune Deficiency Syndrome (AIDS) and your participation 
in the hearing that was conducted on August 1-2 by the House Intergovernmental 
Relations Subcommittee. 

Mr. Alan P. Brownstein, Executive Director of the National Hemophilia 
Foundation^ reques ted that I respond to a question that you had asked concerning 
the development of a blood test to detect the AIDS carrier state. As 1 am sure 
you can appreciate, there are many variables (including chance) that would 
affect the amount of time and funding support that would be required to develop 
a test that was sufficiently specific and sensitive to detect AIDS or markers 
for AIDS in individuals who were asymptomatic but whose blood was potentially 
infectious. In my opinion, the first step would be to develop a collection 
of white cells and plasma from a large number of individuals at high risk for the 
development of AIDS and analyze these stored samples when AIDS developes in those 
who donated these blood samples. Given the long incubation period associated 
with AIDS, this would require at least 2 - it years and a $2 - 5 million 
investment. The specific cost of such a study would depend upon how many 
individuals were included in the sample, how frequently they had samples taken, 
and where the study was conducted--c 1 earl y , high risk areas would be more 
likely to provide useful rnformation. 

Another more broadly based approach depends upon a better understanding of 
the immune deficiency in AIDS through basic research. This would also help in 
developing a suitable blood test. 

1 wish I could be more specific about such an effort, but our level of 
understanding of AIDS limits our ability to provide a definite answer at this 
t ime. 

Once again, I am most appreciative of your commitment to help us learn 
more about the etiology of AIDS and its treatment. 



Al'C- 



r/Jc^ -7:.c^ CU^-^^^ 



Sincerely yours 



A. P. B 



rowns tei n 

- 19 WEST 34th STREET 




Cha I rman 



. SUITE 1204 . M^M:^ V«Hk tof 2 f^J)' hM^ '1 



ry Counc i I 



70 

Mrs. Boxer. Dr. Compas, I was rather shocked by what I am con- 
cluding as a result of your testimony. It appears to me that the 
Haitian community was branded as an entire community before it 
should have been, and that because we used sloppy techniques in 
interviewing the patients, that it is your conclusion that the Hai- 
tian people who have AIDS are the same high-risk population as 
the American population, if you will, and that, at this point, you 
say in your testimony on page 5 that you have received no official 
answer from CDC on discussing this problem. 

My concern is, if, in fact, it turns out that you are correct, and 
they were wrong, and they had sloppy information, that you have a 
stigma on your community, and if that should be the case, do you 
think it would be incumbent upon HHS and this Government to 
really clear the name of the Haitian community in terms of its not 
being any different than any other community? And should that be 
done, if this proves to be the case, with a massive public education 
effort? 

Dr. Compas. Yes; definitely. 

We did not receive any help from any agency. Federal or local, 
for education in our community. 

It isn't true that the community did not do any good work, and 
the classification was totally premature. 

Mrs. Boxer. I understand, but would it be your desire, should 
this prove true, that there should be a massive public information 
campaign to make the truth known, because it seems to me from 
what you say there is great prejudice against children, hiring 
people. It seems that we have caused a lot of pain and suffering to 
an entire group here. 

Dr. Compas. Yes, because all Haitians in general have been clas- 
sified as a high-risk group, and people, let's say professionals, lay 
people, people working as maids, or whatever type of work they are 
doing, were stigmatized or fired from their jobs, and definitely, if 
the truth comes to light, the American Government has to do a 
great deal of education to the American public to make them 
known what is the truth about the Haitian community. 

Mrs. Boxer. In other words, if we have been wrong, we better 
admit our mistake because an entire community has been stigma- 
tized. 

I want to move on to Ms. Apuzzo here. I have had a very sirnilar 
experience, as you have had, in dealing with Dr. Curran, and given 
the fact that I am a Member of Congress, it has been a little bit 
frustrating for me in trying to set up meetings and get information 
and data. 

Do you know of any other health crisis in the country where the 
Congress has had to really push the health officials? In other 
words, it seems to me from my experience as an elected official, 
and although I have only been in the Congress a short time— I 
have been in local government — that it is the health people that 
have come before us elected officials and tried to really fight for 
funds, money. In this case, I see a very reverse type of situation, 
where it is the Members of Congress that are really pushing, and I 
wonder that in your research you might want to comment on 
whether this seems to be a different kind of attack. 



71 

Ms. Apuzzo. It certainly has raised suspicions in our minds, Con- 
gresswoman Boxer. 

We only have to look at an instance like Legionnaires' disease, 
where I don't believe the public health officials had to come to you 
to say, don't push us; we are doing a great job. I believe they were 
serious and directed, and very above board in pursuing a rapid re- 
sponse, and they should have been. 

I believe that we make a terrible error when we pit groups in 
need against each other. 

My own response, and Mr. Endean certainly can share his, is 
that we have virtually had to tug every inch of the way, and I ven- 
ture to say that neglect is never benign. 

If I have suggested that the neglect has been malignant, I mean 
to suggest precisely that. I believe if we have left the Haitian com- 
munity, the gay community, if we have left the I.V. drug users 
standing by to be consistently vulnerable to a life-threatening dis- 
ease, then we cannot call that benign neglect. 

Mr. Endean. Congresswoman, we faced enormous difficulties in 
this process. On the one hand, the administration and many public 
persons say, don't throw money at a problem. 

On the other hand, as Ms. Apuzzo has alluded to, we have had 
incredible difficulty in finding out what is being done, and what 
could be done that is not being done. 

We have seen a consistent pattern here that leaves us at a very 
significant disadvantage. When the supplemental appropriation 
was being marked up before the House subcommittee, the adminis- 
tration made clear time and time again that we did not have need 
for AIDS money, and at the very same time as that was being 
marked up, Dr. Brandt was testifying before Congressman Wax- 
man's subcommittee, and on significant probing, it was discovered 
that they were not sure whether they did or did not, and they 
might have to ask for an emergency supplemental, and in the final 
situation, $12 million was put in the supplemental, and we are 
very pleased with that, but it is not enough, but there has been a 
consistent pattern here that leaves many of us that are attempting 
to advocate for increased funds at a significant disadvantage, and 
you are quite right: For a public health emergency of this sort, I 
think many of us are baffled as to why we have to be pushing as 
hard as we do. 

Mr. Weiss. Thank you very much. 

Mr. McCandless? 

Mr. McCandless. Before I ask my questions, I would like to start 
by saying I am not an insensitive person. You are here before us, 
so that we may try to find solutions to problems. If my questions 
tend to take on some kind of a connotation, it is not intended. 

I would also like to comment that this is a number-one public 
health priority, Ms. Apuzzo, and I certainly don't mean to place it 
in a second-rate position, but for those of us who have had loved 
ones die of cancer, we may find it a little difficult to accept this as 
the No. 1 priority for public moneys. 

If I had the disease, I would probably think entirely different. 
The area that I have some problems with is the information that 
the staff gave to me as a beisis for participation. 



72 

It indicates that there are certain personal habits completely sep- 
arate from homosexuality that have a direct bearing upon the pos- 
sibility of acquiring the disease. 

For example, a report indicates that 90 percent of the patients 
involved have used nitrate inhalers, an intravenous drug. I would 
compare this to a person having a problem with his liver and being 
subjected to a cirrhosis type of indication, and continuing to drink 
alcohol. Certainly the cirrhosis of the liver is going to get worse 
rather than moderate itself. 

What I would like to know, Ms. Apuzzo, is have you or and your 
organizations produced anything in the way of a self-awareness 
program on the lifestyle of individuals and what they might or 
might not do in order to prevent the disease? 

Ms. Apuzzo. Sir, I appreciate your refutatory comment. I appre- 
ciate an opportunity to address the question, because it is a diffi- 
cult question, and difficult questions don't have simple answers. 

I would say to you parallel to your question, sir, that there is a 
high correlation between smoking and lung cancer, and yet we con- 
tinue to pour, appropriately, money into the cure of that dread dis- 
ease. There is a correlation between other behaviors and other dis- 
eases, and we continue to seek the answers to those diseases. 

More specifically to your point, what you raised is a question 
that we have faced every day since we have had to deal with AIDS, 
and the question basically is the distinction between diagnosis and 
judgment. 

Each time we have had to deal with the issue of diagnosis, there 
has been attendant to that diagnosis a judgment. 

I submit, sir, that it is not the purpose of government to judge in 
the face of a crisis. It is the purpose of government to solve that 
crisis. 

But let me go one step further. 

You could raise a variety of specific instances, I am sure, that 
would not be easy questions to answer, but I would beg you, to take 
some cognizance of what is the oppression of a gay male or a lesbi- 
an in this country. Not as an excuse, but symptomatic of that op- 
pression, there is a style of life that might not be the style of life, if 
we were not unable to share domiciles together in many States. 
One cannot live together. There is, in an attempt to take a short- 
cut, there is a series of circumstances that mitigate against gay 
people simply growing up and living their lives minding their own 
business. 

You don't need me to tell you that. I would submit that just 
anyone from this community coming up here could tell you that. 

In terms of the amyl nitrates and butyl nitrates, those questions 
should be addressed, as I am sure they are, in the testimonies that 
I have read by Dr. Bruce Voeller. 

Mr. McCandless. I understand that, but my question was, 
shouldn't you, as executive director of the National Gay Task 
Force, and Mr. Endean of the Gay Rights National Lobby, and as 
leaders in the communities you represent, make certain awareness 
programs available. 

Ms. Apuzzo. Absolutely. 

Mr. McCandless. I got a dialog completely separate from that. It 
I want to continue to drink Scotch, it is self-induced 



73 

Ms. Apuzzo. Let me assure you, sir, that the hotUne that we 
have, every Hne is filled and has to be filled, every person request- 
ing information gets information, and we alert the person as to the 
risks of what has commonly been called "fast lane." 

We have invested an immense sum of money in public health 
education literature that has gone out, and every organization in 
the gay community that has been involved over the course of these 
last 2 or 3 years has produced literature advising our community 
about what constitutes at-risk, and what behaviors put persons in 
the category of at-risk, and have urged people to consider very 
strongly their personal lifestyles and the necessity to address those 
lifestyles in a manner that will bring them into well being as op- 
posed to illness. 

Mr. McCandless. Thank you, Mr. Chairman. I have nothing else. 

Mr. Weiss. Thank you, Mr. McCandless. 

Mr. Levin? 

Mr. Levin. Thank you. 

Let me, if I might converse with you, Mr. Brownstein, because I 
found that there is a somewhat different experience that you had 
in your organization, in dealing with the Government, than was 
the flavor in the testimony of the other witnesses. And thank you 
for all of your testimony. 

I think it has been most helpful. 

How do you react — I don't want to put you too much on the spot, 
but you have had a lot of experience in a field dealing with the 
Government, and a lot of experience obviously in the public health 
field dealing with perhaps one sector, but, as you have testified, it 
relates to others. 

What is your comment, forgetting about motivation for a 
moment, as important as that is, what reaction do you have to the 
experience in this battle with the Federal Government? 

Mr. Endean testified about the slow and inefficient response of 
the Federal Government, and the testimony of Ms. Apuzzo, that 
the Government responded with lack of speed, especially in com- 
parison to that for Legionnaire's disease. 

Mr. Brownstein. I have two responses to your question, which I 
think is a very good one. First of all, it was not until July of 1982 
that CDC first announced three cases of AIDS among hemophiliacs; 
that is quite some time after AIDS had been identified in the gay 
community; so I think that in relative terms, the hemophiliac com- 
munity were newcomers to this. 

So, in a way, we have had the benefit of the most recent increase 
in public awareness, so we are at the eclipse of the awareness that 
comes from the Government, from the Congress, and we are seeing 
increased activity going on. 

Quite frankly, we went to our medical community, and we asked, 
what needs to be done, not just for this hearing, but for numerous 
meetings that we have had over the past year due to this crisis, 
and we have identified certain areas, and we have reason to be- 
lieve, that these areas are being addressed and the timetables for 
reviewing research grants have been compressed to the point prac- 
tical. 

That is part one. 



74 

Part two is that surely everything is too slow. It is much too slow 
when you consider that 1 out of every 500 severe hemophiliacs has 
contracted the AIDS problem to this very date. We want a cure to- 
morrow. 

Daily, myself, and chapters, and our medical people throughout 
the country, are in daily contact with hemophiliacs, mothers who 
call up and say, I infused my child last night, and I am afraid that 
that infusion had AIDS in it, but we know that that is not possible 
to determine, knowing the incubation period, but these are very 
real fears, so it is too slow! Yes, it is, and our frustration calls out 
for a cure. 

I cannot comment to your question as it relates to the Govern- 
ment's response 2-3 years ago, when it became apparent that this 
was a major problem, but, as we are seeing it now, we see the ad- 
ministration and Congress, we see all this activity, and all of this 
contributes to increased awareness and support, so the slowness 
will become, hopefully, more rapid. That is my response. 

Mr. Levin. Let me ask Ms. Apuzzo or Mr. Endean, have either of 
your organizations tried to put together what a more comprehen- 
sive plan might look like? 

I know it is very difficult for you to do that, but the prime focus 
of these hearings will be on that question, or it is at least one of 
the major areas of attention, with the human tragedies beyond de- 
scription, and — I hope — I think all of us are deeply troubled by it. 

We also want to try to embody that in some kind of response 
here that makes sense. 

Do you have any guidelines for us that you would like to throw 
out at this point? Perhaps it would only provide some useful mate- 
rial for us to consider before we talk with the Government wit- 
nesses. 

Mr. Endean. The Gay Rights National Lobby has lobbied Con- 
gress for a number of years now. A primary focus until recently 
has been on securing civil rights and equal justice for gays and les- 
bians. 

Our focus has changed dramatically to look at the AIDS issue. 
However, we are a small organization, and we face, as I suspect the 
task force and other organizations face, enormous difficulty in get- 
ting the facts about what is and is not being spent, what is and is 
not needed. 

So I have some difficulties, frankly, giving you the guidance as to 
all of the details of what should be done that is not being done. 

It seems to me that administration and public health officials 
who know from the various institute heads, for instance, what they 
believe would be needed, have, when they come up to Capitol Hill, 
been gagged. 0MB does not let them spell out what is and what is 
not needed except within the confines of the budget that they 
choose to dictate, so I am at somewhat of a loss to really give you 
the guidance that I think you need. 

It is my hope that these hearings will play a major role in get- 
ting a clear handle on what is needed. Clearly, we have not even 
scratched the surface at the present. 

Ms. Apuzzo. If I may just add to that, sir, and I know Dr. Voeller 
and Dr. Conant will be much more specific in their recommenda- 
tions to you as a result of their expertise, but I would say from one 



75 

lay person to another, where this is concerned, we need animal 
models and we need them rapidly. They are very expensive. We 
probably ought to look at each and every body fluid, and probably 
over a 2-year period of time, because that is what is being hypoth- 
esized as the incubation period. I don't know what the parameters 
are in terms of the number of animals, but I have seen models that 
suggest over a 2-year period of time in each of the six body fluids 
that one could spend $193 million. That does not take into consider- 
ation a beefed-up epidemiological program that really takes confi- 
dentiality seriously and provides data we can have confidence in. 
That does not take into consideration public health information, 
which has to educate fast, and that does not take into consideration 
a real partnership with the affected groups, so we can, in fact, 
work together to get to the bottom of this, and it does not take into 
consideration patient care. I am sure I have left some things out, 
but I think, if we continue to think in terms of $10 million, $25 
million, and think that those sums seem very large, that they will 
solve the problem, then I think we are foot dragging. 

It appears to me, and I said before Mr. Natcher's committee 
sometime ago, that we have a National Academy of Science and 
the best minds available, if CDC and NIH cannot come up with a 
program that says, this is what is needed over this much period of 
time, and this is what it will cost. Again, to gain our confidence in 
that program, perhaps it is time to go to another body that I under- 
stand was put into effect to apprise Congress of scientific issues 
when they needed to call upon it. 

Perhaps it is time that we look to another group of experts to 
assist us in putting together something that frankly all of us can 
have some confidence in. 

Mr. Weiss. Thank you. 

Mr. Craig? 

Mr. Craig. Thank you very much, Mr. Chairman, and special 
thanks to all of the panelists. 

I am at a point of being confused as to what questions to ask, 
because I see a variety of accusations and immediate contradictions 
flying in the whole testimony of the panel. Let me address, first of 
all, the issue of discrimination. 

My reaction to that issue as it relates to the testimony I have 
heard this morning is, if you were here testifying on the issue of 
cancer, as we now know it today, the issue of discrimination would 
never arise, because it is a nondiscriminatory disease. 

It appears from the evidence that is available today on AIDS, 
that it is apparently discriminatory to a point. If you are to talk of 
the disease based on the information that is available today, then 
by the knowledge of that information, you have to speak about cer- 
tain groups of people and certain communities or lifestyles, and in 
so speaking of the disease, the accusation can be made that in 
speaking of it, you are discriminatory. 

I question, then, the accusation that is made, based on that kind 
of logic which I don't find too faulty, as it relates to blood, and a 
person who is on the threshold of studying this problem recogniz- 
ing that it is blood related. Then if we are to speak of blood, and 
you have to in the confines of this disease, and you speak of com- 
munities with which the disease seems to be prevalent, you, by 



76 

that relationship, develop a problem. I remember Government re- 
search officials in the early stages of other areas of research 
making statements that were later found to be totally faulty. But, 
based on the early information, they thought they were being re- 
sponsible in making those statements. 

If I could be so crass as to say cyclomates are carcinogenic — now 
it is questionable whether they are at all, but we went through 
that era, and we have that problem. I think that Mr. Brownstein 
mentioned today in his testimony the tremendous complication in- 
volved in the intricacy of what we believe to be involved with this 
disease. 

You would not be here today, Ms. Apuzzo, if it were not for all 
that has transpired since 1981. 

You would not have been here in 1981, because this hearing 
would never have been called. We simply did not have even the 
preliminary research we have today which is beginning to identify 
the extensiveness of the problem. So I look at the record, and I am 
not saying you should not be a prophet of action, and hopefully this 
committee can respond in a reasonable sense as it relates to dollars 
and a course of direction in assisting with CDC and NIH, but from 
1982 to 1984 this Government has spent $37 million, excluding the 
supplemental twelve. Look at legionnaires: we spent $18.5, and yet 
you say, that was an immediate call to action, and the timeframe 
was 1976 to 1984 for the expenditure of those dollars. 

I will agree that when you look at the report, there were 2,700 in 
that timeframe that were identified as having contracted legion- 
naires with an 18-percent death rate in a much shorter timeframe, 
but only because the research has gone on and the collection data 
has been brought about. 

We are now able to determine some 2,000-plus cases, with nearly 
a death rate of 38 percent. 

If you look at toxic shock syndrome, $8.2 million to date was 
spent by the Federal Government. 

We have now appropriated and/or spent over $40 million to date, 
and obviously a great deal more will now be spent or else the Sec- 
retary of HHS would not have called it the No. 1 medical problem 
in this country today. 

Based on the research I have read, I think we are beginning to 
respond with a great deal more urgency, and they will respond 
with a great deal more urgency since it is now recognized to be a 
specific emergency. 

I believe that if you would look at the past, the present, and 
what we perceive we must now do in the future, that I could find 
selected areas of criticism. However, the record bears rather clear- 
ly that this Government, based on its knowledge, this administra- 
tion, on history and the record, is beginning to respond faster than 
they have ever responded to anything else. It is beginning to re- 
spond in an appropriate fashion, and it will be this committee and 
your assistance that will bring that kind of response at a much 
more rapid rate than we have seen in the past. 

Mr. Weiss. Although your time has expired, I think it is only fair 
to allow the panel to respond hopefully ever so briefly. 

Mr. Craig. Thank you, Mr. Chairman. 



77 

Mr. Endean. Congressman, I am glad you raised the issue, be- 
cause since Secretary Heckler proclaimed AIDS the No. 1 priority, 
the administration has not modified its initial 1984 budget propos- 
als. Those are woefully inadequate. The administration proposals 
for fiscal year 1984 are less than already has been spent. With all 
due respect, I think we are seeing a rapid speedup in rhetoric. 

I grant that. I think that the administration has spoken out 
forcefully. It has not spoken out forcefully to its budget offices, to 
the appropriations committees, subcommittees, or to the Congress. 

Without that kind of action, it remains, in my view, so many 
words. 

Ms. Apuzzo. I think it is difficult to acknowledge perhaps, from 
your perspective, that the Government could, in fact, be discrimi- 
nating against any group of people in this country. From my per- 
spective, it has been a part of my life. From the perspective of 
those who are persons with AIDS, ask them. 

When you say that the administration is now speeding up, I can 
respond to that; I can have hope in that, and I can be willing to 
continue to work and encourage my community to continue to 
work, but I have to say to you, sir, we now have upward of 1,902 
cases in this country as of a couple of days ago. That is a long time 
waiting, and it is very, very costly waiting, sir. 

Thank you. 

Mr. Craig. Thank you, Mr. Chairman. Recognizing the time 
limit, let me conclude on the discrimination issue that Ms. Apuzzo 
talked to 

Mr. Weiss. You have taken twice your allotted time. 

Mr. Craig. I appreciate that, Mr. Chairman — and I will make it 
very brief — I don't think anyone in this Government chooses to dis- 
criminate. 

There may be exceptions, but I do recognize that whon you single 
out a problem that may address a select group of people, depending 
on your sensitivity to the problem and the group, that can be, and 
oftentimes is, construed as being discriminatory. 

Mr. Weiss. If members have other questions, of course, we will 
provide the time for addressing them to the panel. 

If not, however, we do have a group of medical people, doctors 
and researchers, who will comprise the next panel. 

I would like to move on to them. 

Mr. Walker? 

Mr. Walker. On page 3 of your prepared testimony, you suggest 
that other high-risk groups have used the Haitians as scapegoats, 
Dr. Compas. 

Would you elaborate on that comment a little bit for me, please? 

Dr. Compas. A few gay people have been trying, in some newspa- 
per articles, I don't remember which one exactly — to relate the dis- 
ease to the swine fever virus and has been saying that we, Hai- 
tians, are bringing the diseases here. Some gay community leaders 
have rejected those accusations and defended the Haitians. 

Mr. Walker. OK. Could you provide for the record some of the 
documentation that you have. 

Dr. Compas. Yes. 

[The articles referred to follow:] 



26-097 O— 83 6 



78 




!.• ■ ■ '!ullhk'll 111 illoo.l (IIIhIUi. Is 
;v, :^-.'l \ I I I ill ll ln.MlUiplllll.H.S roi;- 

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uliinnis'i iiiiiii .11 Ml. 111! \ 111 

■ isiiili.iU'il lii'iii iii.iin iIiIUt 

1 .;■!: .lulu^c^ .1 iniKI lIimihIci 

■ , , .-J II III -n 'n (luioK iinrmiiin 

•n.' iil>. Ill iIk- .ihscllCC ot lllc IK 

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I ' •- iliii 'liiv niiiil iiniiuiiliiMippri's 

:>!■■. lup.iv.' luMiui|ililli.Ks I'> .1 

iii.,l''>i iiii> iii.i\ hi- iIk' 

i 'n M. I.\ ;• Ik'iiiiiiMiiIiji. \ Ji'voiiip 

'1'- '■'. si.;:.ji'-is !i',.il .III iiu'i'sliu.iiion •'! 

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: ;•• .i.-.il^ 1. >...■, 1 null 

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■ spi.siir.' I'.i i.K In; \ III 
•.-ri N III uninlnli.K s ii' iIk' ,is 

■ o. .lyop : it Mirs 

A Married Haitian Couple in Pans 
Dies of AIDS 




111 I I tiuinuui. r' ill icporied m J 
iiT'-'i lo ilic liinccr (Md\ '^. pjiif K'40) 
ijiii .1 lluiliJii couple liviiiy 11) Purii dicil 

■ 1 .pp.n ■uiiislK mtccnoiis iiiosl probjhly 

csu'iiiii. iioMi AIDS The 31 -year-old 
n ■. h.i,, hwil in Pjiis miki- I '■'V'-'. and 
vv . i.'si jdiniikd lo .1 hospiul there in 

ii'- Mu .ik'il 111 I ekriijr\ U)8' She 
■!i.. iK.i lived 111 Newjrk, New Jersey. 

'•..,, M.i'. h 'o Sepieinher 1 ')S0. during 
ulikli nine >lie h.ul sexii.il rel.ilioiis willi 
.iiioiliei ll.iili.iii (ni.ile) Her \iiKTk;ii' 
M'Mi.il p.iiiuei died ol AIDS iii .lanii.ii\ 

I OS-. 

Ill-I ^^-W.ll I'ld llll-.ll.llld lk-\OI MMIed 

;|u I S III .iiii\id 111 I'.i'is 111 Oiliiisei 
I'l.M iikl \'..is llisi .idiiiilled k' .1 hospilil 
.ju'c 111 (ki. il'ci I'l^l lie died kuii 
11. mills l.iki /This K-pnii seeing k' i:i\e 
luiie weiehl IoTTk uoiioii ihai MPS has 
i..;in.iled 111 Main, .ind his keen spie.id 
ihe I .S ,iiid 1 iirope lioiii llieie 



Gay Men and Anorectal Cancer 

In ., icik-i k' ihe Ji'iinhjl <'l nw \iiici 
II .III W((//c,/i' IW'lltinnll (\1,i\ i i p.i^^ 
:4siM Bilk. \ ihIKm I'll |) Lik' iiiedi 



anal inleuniiise OMier siiidies sliouM in 
elude i;a\ men who .k i e\elusivel\ .is anal 
penelraiors ,iiid i;.i\ men who act e\elii- 
sivelv as anal reeipienls who uv oil liihri 
...mis. and leupieiils who use w.ilersohi 
hie . non-oil luhiieanls 



Interferon Therapy for KS 

Inierleron i> a small protein produced 
In a livini: cell in response lo inlectioii In 
.1 virus Interleron in.i\ ;jo on k> cause 
lesisi.iiKe ki -inolliei iiilei.lion In ihe vi 
Ills 111 even inleiliou b\ .idilleieni vniis 
Inlerlerons either ii.iliiialK loinied oi 
pkkhked in l.il'or.ikincs ha\o lieensliowi! 
lo l-e oi^.isloii.ilK ^.ip.ikh 'I I'diihllliiL 
ihe .jioulh ol ^eriain kinds .u iiiiiii'is h' 
k'lleion ill. IN .liso iliodlU the ^.mise ii 
Mill luUk noils 111 Ir.iinans ii. Iiidnie hep 
.ilills H .ind . \ loiiKu.ilii' II IIS 1 1 \1\ link 

ll.ii' l';-is|,Ii III I \t\ 111 I.-.. Ii 1! ■ 111 '.;.l\ 

I'len ':.i\.- beep .oiisnlrie.l is i |i.iss|li|,- 
.iiuc .'I \ 1 1 )S in ! Ii.iv. keen .is«. h i.i i. .1 
»,lli kS .IS ,vc|l 

I he . I kkis ..I a p.i; IK mI 11 km. I -.1 ii. 
.iieior .Ml li.ini.'-es n.ii in-'U uilli K's 
■ . 11 jMeseiik-d. in lli ■ ' '(/■■.-.;• • •'.-. 
I "I, -.1, ,r !/../(, ,;/ li\.'. ..;./.■■ I \l r. c. 
pj.^c lll~l| k\ Su-.iii 1 kiii\\ii ind lu I 
Liilli icues 0: ki.nui .idiinillsli.ied liliei 
kii'ii In I ■ MI'S p.iiienis \\h,i h.id k.S 
live denioiisi laied .i niajoi pnsiiue k 
spouse .ind iliree h.id .i iiiiii"! tempoiaoi 
lesponse 1 liese data siigjicst ili.it inlei 
leron may prove uselul in treating KS in 
AIDS viclnns. and also thai interferon 
may restore at least some aspects ol cell- 
mediated (Tcell) immune tiincltons 
Some chcinotherapcuiic agents used to 
treat KS have an iinmunosiipprcssive et- 
tect Interreron ma\ he particularly ad- 
vantageous because it does not produce 
these untoward immuiiosuppiessive el 
lecls a factor ot great importance in 
treating AIDS vicliiTis 



Wear Condoms- 
Reduce Your Risk of 
Contracting AIDS 



Rescikli |i.ipersaiid comnienisappeai 
inj; 111 ihe mediial liieiaiure implv ihai 
ur.inikj . ondoiils ki puv.iil seiiun lioiii 
enkiine one s pailnei s k...h ni.r, have .i 
role in pieveniinj; \1DS .Se\ii.il prac ikes 
bv which semen is received or illv oi .inal- 
l\ h.ive.ol couise. cominoiiK oicuiied 
ihioiiulioiil ilk hislorv .11 huin.in sexu.il 
iiv l-i>r ihe piiscnk li.iwever. the risk ol 
..;ettiiis: AIDS rec|Uires certain precaunons 
III si-\u.il pi.Kiices ih.il involve exposure 
I,, scinen. uiiiii- k • es. .iiid blond. Il iheie 
IS .1 , aiisaliM- .kJeiil vd AIDS, like a viius. 




79 



ABC NEWS 20/20 

May 19, 1983 

HUGH DOWNS: Ciood evening. I'm Hugh Downs. And this is 20/20. 
ANNOUNCER: On the ABC Newsmagazine. 20/20. tonight: 
AIDS — an incurable disease. 

Dr. MARCUS CONANT: I think it's naive to believe that the AIDS epidemic is going to 

remain confined to one small segment of the population. I think this is a problem for the 

entire American public. 
ANNOUNCER: The most frightening epidemic since polio: 80 percent of its victims die. 
and reported cases arc doubling every six months. Firet identified in the the homosexual 
community, now it's in 35 states, and the nation's blood supply may be threatened. Did 
moralistic attitudes delay the medical counterattack? Did prejudice give AIDS a fatal head 
start*^ Geraldo Rivera, with.a report on the mysterious killer called "AIDS" 
Bene Midler — what drove her tc the top? 

AARON RUSSO: She thought for about three seconds, four seconds, and said. "I want 

to be a legend. " And when she said that to me. it made everything very clear. You know. 

I knew exactly what my job was. 
ANNOUNCER: His job was to make her a national star. Bette Midler — abrasive, provoca- 
tive, often outrageous on stage, ofhtage she's been called a shy and private person. 

BETTE MIDLER: I should have been something just a little more conventional, like a 

teacher or a — and I would have been a wonderful teacher. 
ANNOUNCER: Steve Fox. with the stoiy of the Divine Miss M — 'Bene Midler." 

LESLIE GEIQER: When I would k)ok in the minor when I had a pair of shorts on. I 

would cringe. My whole body image was tied up in my thighs. 
ANNOUNCER: Cellulite — the warm weather embarrassment Women work to tose it. and 
they spend millions of dollars to do it. They're slapped, steamed, wrapped and bagged — but 
does it do them any good? John Stossel reports on the treatments of "Cellulite: Fad. Fact or 
Fantasy?" 

DOWNS: Up front tonight, A-I-D-S. AIDS, tfje most frightening initials in America today. 
They stand for Acquired Immune Deficiency Syndrome, a medical mystery thai destroys the 
immune system, and leaves our bodies defenseless against unusual and deadly infections. 
And yet, wide publicity and public funding for an attack on this dangerous disease have only 
recently begun. Why the delay? Here is Geraldo Rivera. GeraWo? 
GERALDO RIVERA: Why ttie delay especially, Hugh, when you consider the fact that 
AIDS has already killed more people than the Legionnaire's Disease outbreak and the toxic 
shock syndrome combined. It is the most frightening medical mystery of our times. AIDS 
has spread worldwide, but apparently it began in equatorial Africa and somehow spread to 
Haiti, and from Haiti to theU nited States. Why? Nobody knows: specialists at the Centers for 
Disease CorttWi. Ihe tUCTFrnik AIDS may be caused by some new virus, but so far they 
have had absolutely no success in tracking it down, even though AIDS has been killing 
people in this country since 1979. 
[clip of memorial march for AIDS victims} 

MAN: Fighting for our lives . . .too little is being done too late . . . 
RIVERA [voice-over]: There is an epidemic kxKC in the land. This memorial march is in 
honor of the past and future victims of AIDS, a so far incurable disease which kills its victims 
in stages. 

BILL BURKE, AIDS patient: I'm tired of k>sing people that I k)ve and I care about. 
RIVERA [voice-over}: The doctors believe that Bill Burke and these other men have it. 

— 2 — 



80 



[interviewing} Every day you hear abou( more people. 

Mr. BURKE: Yeah, a friend of mine's going for biopsies today. Another friend of mine died 

two weeks ago. And every week, somebody else comes down with it, or somebody I know 

goes into the hospital who had been doing well. And it's heartbreaking. It's heartbreaking. 

RiVERA [voice-ever]: Heartbreaking and terrifying. Bill and these other men seem to be 

doing pretty well, but alt of them know that 80 percent of all AIDS victims are dead within 

just two years. This is easily the worst epidemic since polk). The story of the birth and 

malignant spread of the killer disease may seem like a scenario from some honor movie, but 

this is real life. 

KEN RAMSAUR, AIDS patient: Before I got Kaposi's. I thought I was a pretty goodkwk- 

ing guy — average, but happy — and now it's — I actually see myself fading away. 

RIVERA [voice-over]'. Twenty-seven-year<jW Ken Ramsaur's case is, unfortunately, typi- 
cal. Diagnosed just last summer, AIDS has already stripped his body of its ability to fight off 
other diseases and infections. Left unprotected, he's contracted Kaposi's sarcoma, up to now 
a rare form of cancer. 

Mr. RAMSAUR: Everything that 1 used to be able to do by myself, I now need tots of help 
with, ar»d it's just scaiy — it's scary the way I'm not what I was. 

RIVERA [voice-over]; And Ken is not dx only one who is scared — but let's trace this killer 
disease back to its beginnings. 

MAN: Free AIDS litetanire — please, learn about the symptoms. 

RIVERA [voice-over]'. In 1979. this is where tf»e first cases came to light, in New York's 
Greenwich Village and within male homosexual conununilies in San Francisco and Los 
Angeles. 

BOB CECCHI, AIDS patisnt: I was going out and meeting people, and trying to find a 
tover, and making tove to people who interested me. I didn't kr»w that, you know, that there 
were things out there so secretly hidden that it was going to destroy my life. 
RIVERA [voice-over]: Because it was first thought limited to this one group, it was known 
then as "the gay cancer," and later, "the gay plague." However, those derogatory labels 
soon become obsolete. 

Or. MARCUS CONANT, Univwslty of Caiifomia at San Prandaco Medical 
Center: J think it's naive to believe that the AIDS epidemic is going to remain confined to 
one small segment of the population. I think this is a problem for the entire American publk. 

RIVERA [voice-over]: When the disease was identified in mainlining drug users, the re- 
searchers were fairly convinced that it was like hepatitis — either sexually transmitted or 
bkxxi-bome. But then, in the fall of 1981 , the mystery became even more ominous, when the 
disease was also diagnosed in otherwise healthy immigrants from Haiti, men who were 
neither homosexual nor drug users. Then it spread to the women who were the sexual 
partners of those at risk. 

Dr. CONANT: If research firnds are not brought to bear on this problem quickly, the 
problem is going to spread throughout the entire country and be a major health problem for 
us. 

RIVERA [voice-over]: Like ink spreading on a bkxter. AIDS continues to claim different 
types of victims. As an example, eight infants bom of high-risk parents seem to have 
contracted die disease. Four have died. And just last summer. AIDS began turning up in 
hemophiliacs, and other people who had leceived transfusions of btood. Some estimate there 
will be 20,000 AIDS cases repotted by the end of next year, [on camera] And so the evil 
genie is out of the bottle. With repotted ca.ses doubling every six months, AIDS has now 
been identified in over 35 sutes arid 16 foreign countries. Of course, the counterattack has 
also begun. Scores of medkal researchers and scientists are shidying die problem. The 
epidemic has also received a great deal of recent attention in the news media, but one charge 
we hear really raises a question for all of us; whether our prevailing social and political 

— 3 — 



81 



attitudes — put more bluntly, whether our negative attitudes about homosexuals — allowed 
this killer epidemic a bizarre and deadly head start. 

LARRY KRAMER, Gay Mten'S Health Crisis: We're into this two yean, and you are 
finally doing a story — Time and Newsweek are finally doing a story. There are a thousand — 
1,600 cases, there are 800 dead people. How many does it take before somebody pays 
attention to it? 

RIVERA (voice-overj: Larry Kramer, a co-founder of the Gay Men's Health Crisis, is 
especially critical of the newspaper of record, the New York Times. 

Mr. KRAMER [on telephone}: The New York Times is being socially irresponsible by not 
relaying to one million members of its community what is affecting them. 

RIVERA [voice-overl: Although New York has about half the reported cases in the nation, 
with about 250 dead so far, Kramer points out that in its coverage the Times has never put the 
AIDS story on its finont page. Contrast that with the front-page prominence given a recent 
herpes outbreak that killed 30 dancing horses in Austria. The management of the New York 
Times, on the other hand, told us they feel they have adequately coveted the story, in any 
case, now tjiat AIDS poses a threat to the nation's bkxxl supply, society and the media are 
finally paying attention. 

rtop. HENRY WAXMAN, (D) CalKomia: Public officials are very influenced by public 
opinion, and public opinion is very much influenced by what the media does. 

RIVERA {voice-overj: Henry Waxman has also been critical of the govenunent's handling 
of the epidemic. He should kiiow; he's chairman of the House Subconunittee on Health and 
the Environment. 

Rap. WAXMAN: We saw when Legionnaire's Disease came into the public awareness that 
there was immediate clamor for action. Had this disease aftlicted children or members of the 
Chamber of Commerce, I'm sure the Reagan administration woukl have been breaking down 
all doors in order to push the govenunent on all fronts to deal with it. 

RIVERA: Has it been bigotry, bureaucracy or budget cuts tfiat have skewed the response to 
this terrible problem? 

Rap. WAXMAN: I think all three of those factors have meant that the f^vemment dkl not 
respond as we should have to this public health crisis. 

Rap. WAXMAN (lo House Subcommittee on Health and Environment. May 9. 19831: 
CDC first identifi»J the disorder in June of 1981 . According to your testimony, 6te first 
NIH grants were made IS months later, and then for only SI 65 .000. 

RIVERA [voice-overj: Bothered by the apparently sk)w initial response to the AIDS epidem- 
ic, both Waxman of California aixl Senator Moynihan of New York have introduced legisla- 
tion requesting $40 million a year for public health einergencies like AIDS. But Dr. Edward 
Brandt, the assistant secretary of Health, is opposed. 

Dr. EDWARD BRANDT, assistant sacratary of Hatfth: I oppose those measures 
t)ecause tttey're not needed. 

RIVERA [voice-overj: And Dr. Brandt is the Reagan administratkNi official to whom all 
public health agencies report, [to Dr. Brandtj It's given the fact that the disease is so 
complex and the ramifications so awfiil, tfie mortality rate so high, 6aA critics say the federal 
govenunent should have done more sooner, nxwe money, more people, nwre research — 
isn't this ihe prototypicai case where emei^gency funding and emergency measures should 
have been taken by the federal government? 

Dr. BRANDT: The issue is. what wouM you have done different? 

RIVERA [voice-overj: What might fiave tieen done differently? Example: with more federal 
money, researchers and scientists at tfie Centers for Disease Control, the CDC. might have 
,been able to keep a closer watch on the spread of this killer disease. 
Mr. KRAMER: The gay community has been trying for nine months lo get the CDC to 

— 4 — 



82 



reinstihite active, serious, in-depth surveillance, interviewing the victims to see who they had 
slept with, what they had done — figuring out the patterns. No one is doing that. 
RIVERA Ivoice-overl: Example: case leporting to public health officials is required for all of 
the following diseases: gonorrttea, hepatitis, German measles, and mumps. Case reporting is 
not required of AIDS, [to Dr. Brandt j Wouldn't it be logical, then, to have mandatory case 
repotting so your experts here in Washington or at the CDC in Atlanta will know exactly 
where the disease is going, and presumably can use that as one factor in the evidence 
suggesting where it came fiom. 

Dr. BRANDT: At the present time, with the heightened awareness in the professional 
community that we have created through articles, through other things, we believe we're 
getting virtually all the cases iqxMted to us. 

RIVERA [voice-overj: But arc they getting all the cases? Example: according to the CDC. 
there are only 27 AIDS cases in all of the state of Texas. But 20/20 has learned that in the city 
of Houston alone there are an estimated 100 AIDS cases. 

MAN [addressing meeting in Houston[: I am an internist in private practice here in 
Houston who is now seeing at least weekly one patient with AIDS, or some depression of 
their immune system. 
RIVERA [voice-overj: When information on AIDS was first published in April of 1981, 
there were five reported cases nationwide and two deaths. By that summer, it was recognized 
as a serious public health problem: there were 108 cases, 43 were dead. In the summer of 
1982, there were 593 cases; 243 were dead. The latest figures: there are over 1 ,400 reported 
AIDS cases; 541 are dead — and that is just the official body count. 
Dr. UNDA LAUBENSTEIN, New Yortc Unhwrslty Medical Center: Things are getting 
worse. There's more patients, more complexity to the situation, more hysteria and no easy 
answeis. 

RIVERA [voice-overj: In March. Dr. Linda Laubenstein sponsored this international AIDS 
conference at New York University Medical Center. Since this is ground zero for this 
frightening medical mystery, the other nations affected arc kx>king to the United States for 
research leadership. So far, tf>ey say, they are disappointed. 

Dr. ROEL COUTINHO, Dutch virologist: ! think I'm a bit amazed that not more 
research has been dorte, because there are so many cases, there are so many opportunities to 
study it. 

RIVERA: In fairness, the federal government does claim to have spent almost $15 million in 
the fight against this epidemic, but most critics maintain that, up until now at least, the federal 
government has not done enough fast enough. Example: it was not until the summer of 1982, 
after it became clear that AIDS posed a threat to the nation's bkxxl supply, thai the National 
Institutes of Health, the major source of research fimding. even issued their request for grant 
applications on the subject of AIDS. As of today. jiBt 18 percent of those research requests 
have been granted, [voice-overj Aside from the classic problems associated with catastrophic 
illnes-s, like inability to work and inadequate medical insurance. AIDS victims must also deal 
with the trauma of being both a patient and a pariah, even in the hospital. 
Mr. RAMSAUR: And one night I heard tvw of. 1 believe they were the nurse's aides, not the 
actual nurses, standing outside my door sort of laughing and I wouM almost say placing bets 
on, now, how k>ng is this one gonna last? 
RIVERA: What did they say, exactly? 

Mr. RAMSAUR: "1 wonder how kmg the faggot in 208 is gonna last." 
Dr. ANTHONY FAUCI, National kwtitutea of Health: There's no question and no 
denying that there is a feeling among members of any of a number of professions, or >ist the 
general population, that patients with AIDS, many of whom are homosexual, arc a little bit 
different. I tfiink that that has probably, at least early on. led to a little bit of a complacency 
about the approach towards this disease. 



83 



RIVERA Ivoice-overJ: Dr. Anthony Fauci is a top govemmenl researcher The anitudes he 
is talking about almost lost him the chatKe to work with the very patient who is the focus of 
his current research. 
RON RESIO, AIDS patient: I was refused at this hospital . . . 

RIVERA [voice-over]; Thirty-sLx-year-old Ron Resio was refiiscd admission to the Clinical 
Research Center at the National Institutes of Health, despite the fact that he had been 
receiving treatment here as an outpatient. 

Mr. RESIO: I had double pneumonia, confirmed by x-rays, arxl a temperature of over 103. 1 
was interviewed, or I should say inquisitioned. by a doctor who kept calling it "the gay 
plague." 

RIVERA (voice-over}: The official reason for the refusal was the feeling that his case did not 
fit into the facility's long-range research plans, (to Mr. Resio} Huw did you get into this 
hospital then, finally? 

Mr. RESIO: When they found out I had a twin. 

RIVERA [voice-over}: The attitude toward Ron changed dramatically, when government 
researchers discovered he had a healthy identical twin brother, providing (hem a textbook 
opportunity to search for a cure. Brother Don flies into Washington for two days every three 
weeks from his home in Vicksburg. Mississippi, where he lives with his wife and children. It 
is Don's healthy whi'e blood cells that are being used to boost Ron's immune system, but it is 
not easy for either man. 

DON RESIO, brottWf of AIDS patient: It's very frustrating to come up here every three 
weeks and watch parts of my brother disintegrate — watch him have trouble with his eyes 
one time, problem with his lungs. Kaposi's, different things — and you just keep asking 
yourself, how k>ng can that go on? 

[clip of memorial march for AIDS victims} 

RIVERA: Whatever your personal feelings about (he homosexual community, the basic 

complaint of these candlelight demonstrators rings tme: until it was discovered that this 

disease posed a threat to the nation's bkxxj supply and began claiming odier less controversial 

victims, we all paid a k)t less attention than we shoukJ have in the beginning, [lo Ron ResioJ 

Do you ever feel like just giving up? 

Mr. RESIO: Not very often. I think one of the things that makes riK a good patient is that I 

am a fighter, and I have decided that I'll be the first one to make it, the first one to get over 

this. 

HUGH DOWNS: We can hope he does. It's a terrible situation. What are the symptoms of 

AIDS? 

RIVERA: There are several symptoms. Hugh. I guess the first most obvious one is swollen 

glands. Then those bruise-like markings on the skin you saw in the piece itself; weight k>ss: 

persistent fever: night sweats: persistent dry cough; persistent unexplained diarrhea. Those 

are the most corrunon symptoms. 

DOWNS: Just today there were some reports of some new cases — women who had been 
the wives or bvers of AIDS victims, and a sanitation worker who doesn't fit the AIDS 
profile. 

RIVERA: First of all, the doctors aren't sure that all of those are suspected AIDS cases, 
although they are showing the early symptoms. The point is, there is no evidence wfiaisoever 
that just casual contact with an AIDS victim will get you the disease; the best evideixre of that 
is the fact that no medical personnel — doctors, nurses — have caught it from their patients 
over the last four years. One way we know you can get it, though, is by bkxxl transfitsions — 
getting contaminated okxxl from an AIDS victim. And that'll be the focus of our next report. 
That's the real threat to most of the rest of us. 
DOWNS: We'll be watching that next week. Thank you. GerakJo. 

— 6 — 



84 



Later in the broadcast, the evolution of a legend. Steve Fox profiles the explosive Bctte 
Midler. But next, summer is almost on us, and people are paying attention to their figures. 
John Stossel pays attention to cellulite, that embarrassing fat. right after this. 

[commercial breaki 

DOWNS: Summertime is coming, time to get into shorts and swimsuits, and time for 
millions of women to worry about how they look in a bikini, because of something called 
cellulite (CELL-u-lectJ — or do you call it cellulite (CELL-u-light|, since it seems to be 
spelled that way? Here is our consumer correspondent, John Stossel. John? 

JOHN STOSSEL: It's pronounced both ways, actually. Cellulite is thai lumpy or dimply 
looking fat that gathers in the hips and thighs of some women We asked people about it on a 
beach, and got strong reactions. Ion camera} What do you think of cellulite? 

I8t WOMAN: 1 think it's gross. 

2nd WOMAN: It's really ugly. 

3nl WOMAN: Ah. it's what you dread! 

STOSSEL: What's it kmk like? 

4th WOMAN: Orange peels. 

5th WOMAN: Wrinkly and bumpy. 

eth WOMAN: Jelb. 

71h WOMAN: Not smooth 

8th WOMAN: Yucky. 

MAN: Big flabby thighs on girls. I don't know. I like, you know, lean woman, you know? 

STOSSEL {voice-over]'. Lean is in today. 

(clip from Richard Simmons Show] 

RICHARD SUMMONS: How many of you have cellulite? (audience yells] I don't think 

I'd shout about it! 
STOSSEL [voice-over]: There's k*s of advice about how to get rid of it. 

WOMAN [to Richard Simmons]: I Hy exercising. 

Mr. SIMMONS: And what happens? 

WOMAN: I get discouraged, because it doesn't go away. 

Mr. SIMMONS: It's not going to go away right away, but if you continue to exercise, it 

will. 
[to exercise class] Come on, get rid of that cellulite! 
STOSSEL [voice-over]: In fact, exercise may not help. That's one of the weird things about 
cellulite — exercise doesn't always lake it away. Even some athletes and dancers who 
exercise all the time still have cellulite. And many thin women have it; just visit diis cellulite 
salon. [10 woman in salon] I don't get it — you're thin, you're five-eight? You weigh. . . 

WOMAN: One-fifteen. 

STOSSEL: And you're worried about cellulite? Why? 

WOMAN: I don't tfiink it mancrs how thin you are whether you have cellulite or not. It's >ist 

a very ugly skin condition, and I have it right here. I'm afraid to turn around half the time. 

STOSSEL [voice-over]: Yet many doctors say tfiere's no such thing as cellulite. 

Dr. LAWRENCE SIEFERT, CalHbmta SocMy of Plastic SurgMns: Cellulite. ak>ng 
with some other products firom France, is an import, but in this case it doesn't mean 
anything. It's a media hype term that is a fancy name for fat. It's fat in Paris, fat in Pomona, 
it's the same fat. 
STOSSEL [voice-over]: It is tnie that when scientists kx>k at fat cells from dimply thighs 

— 7 — 



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92 



An epidemic of myths and misperceptions. 



The History Of An Epidemic 



By Robert Bazell 



1 STEPPED OFF a plane from Port-au-Prince the other 
day, and Ihe immigration officer at Kennedy Airport 
refused to touch my passport. Because I had been to Haiti, 
he was afraid he might catch AIDS from me. 

In A Distant Mirror, Barbara Tuchman notes that even 
though the Black Death of 1348-50 lulled one third of the 
population living between India and Iceland, the 
disorders of the time could not be attributed to that cause 
alone. There were many other problems which "existed 
prior to the Black Death and continued after the period of 
the plague was over." 

The effects of AIDS cannot be understood without 
considering the preexisting problems of certain groups — 
not only the homosexuals, drug addicts, hemophiliacs. 
and Haitians to whom AIDS is a plague, but also the 
medical reseaitl* establishment and the mass media. The 
immigration officer's reaction is part of a hystena afflicting 
many people in recent months, especially on the East and 
West Coasts: AIDS SHOCXER AT BEIXEVUE, screams a 
headline in the New York Post. "One thing we do know lor 
sure," shouts Ceraldo Rivera, "this dreadful disease has 
spread well beyond its original bounds " Suddenly a lot of 
people fear that they and their families might suddenly 
catch some mysterious, fatal illness which until now has 
been confined to society's outcasts. 

This is indeed a dreadful disease, a horrible epidemic 
that will kill thousands before it is over. It is certainly the 
most serious public health emergency in the United States 
since polio was controlled- The cause is unknown, and 
there is no cure. But AIDS is not going to kill your 
grandmother. 

In 1981, when the first cases were identified, AIDS had 
no name. Doctors in New York and San Francisco 
suddenly saw relabvely large numbers of pabents with 
rare diseases — particularly a carwer called Kaposi's 
sarcoma and pneumonia caused by the bacterium 
Pneumocystitis carinii. AD of the victims were young 
homosexual men. Doctors quickly learned that the victims 
were contracting these rare diseases because part of their 
immune system — certain white blood cells cruaal lo the 
body's defense agaiiut mfection — had been destroyed. It 
was not until last summer that someone (there is 

Robert Bazell, who studied immunotogy at the University 
of California at Berkeley, is the saence correspondent lor 
NBC News. 



confusion about who) thought of the name Acquired 
Immune Deficiency Syndrome. Later, when investigators 
from the federal government's Centers for Disease 
Control (CDC) searched their records, they realized the 
disease had first appeared in New York in 1978, and that 
there had been at least seven cases in 1979. 

When Ihe doctors m New York and San Francisco first 
recognized the syndrome, they contacted the CD C. in 
Atlanta. The CD.C. tracks down the causes of unex- 
plained outbreaks of illness. It is staffed by physicians and 
scientists who are highly competent, usually young, and 
invariably willing to work for less money than they could 
make on the outside TTiey en(oy the role of medical detec- 
bve. Often their tasks are relatively trivial: finding the 
tainted macaroni salad which gave diarrhea to dozens at a 
crowded picnic. Sometimes Ihe challenge is much greater, 
as when CDC. scientists identified the bacterium respon- 
sible for Legionnaires Disease, and turned a mystery killer 
into a treatable ailment 

Much has been said and wntten about the allegation 
that because AIDS primarily affects homosexuals and drug 
addicts, the federal government was lax in responding to 
it. I carmot say that more researchers and case workers 
would nol have been assigned if this were a fatal affliction 
of mvestment bankers. But it would be difficult to make a 
case that the CDC could have accomplished more than it 
did in the initial phases of ttie investigation. 

The science of epidemiology ccmcentrates on finding the 
one exposure shared by those infected by an ailment and 
not by those unaffected by it. "At the picnic did you eat the 
potato salad or the macaroni salad?" In the early stages of 
the investigation in 1981, theC.D.C. saentisis exhaustive- 
ly interviewed every AIDS victim they could find. They 
tested samples of the victims' blood, urine, saliva, and 
feces for every known bactenum, virus, and parasite. 
Many theories were put forward: that the amyl nitrate 
stimulants kno%wn as "poppers" were the cause, that 
certain bathhouses or bars might be involved. The labora- 
tory tests found nothing. The only fact that emerged 
<rom the interview was that many of the victims were 
having a lot of sex with a lot of other men. Many had had 
hundreds of sex partners a year, and some had had more 
than a thousand. 

Ironically, the investigation moved faster at the begin- 
ning stages precisely because the disease was affecting 
pnmanly people whom most of society and the mass me- 



14 THE NEW REPUBLIC 



93 



•di» tend to ignore During those first months CD C sci- 
entists did not have to contend with hystencal inqumes 
from citizens and public officials They did not have to 
spend much time answering reporters' questions, because 
reporters weren't calling. 

Between 1979 and the end of 1981. 280 cases had been 
diagnosed and reported to the 
CDC 225 in 1981 alone. The 
number seemed to be increas- 
ing exponentially, doubling ev- 
ery six months. The investiga- 
tors saw that AIDS had spread to 
drug addicts, to Haihans. to he- 
mophiliacs, and to children. 
They realized that 75 percent of 
the victims who had had the 
disease for a year and a half or 
more were dead. And most im- 
portant, it became incrcasinj^lv 
clear that what was causing the 
disease was something "new": 
not the familiar bacterium wait- 
ing to be found in the macaroni 
salad, but an agent to which hu- 
man beings had never pre- 
viously been exposed. At this 
point it was obvious that tradi- 
tional epidemiology and the re- 
sources of the CDC. were not 
enough. A lot of basic research 
was needed. And here there 
was a lag. 

The Nahonal Insbtufes of 
Health dominates medical re- 
search in the Urated States. The 
N.I.H. is not set up as the 
CDC. is to respond quickly to 
emergencies. It funds research 
and researchers to pursue long- 
term goals that are established 
by Congress and, indirectly, by 
the lobbying groups that influ- 
ence Congress. That is why the 
largest part of the N.I.H. budg- 
et pays for studies of diseases 
which might kill a 68-year-old 
white male Senator. Not sur- 
prisingly, the top scientists fol- 
low the money. Most spend 
their time on problems such as 
cancer and heart disease. The N.I.H. offered no money for 
AIDS research in 1982. But even if it had. few top scientists 
would have jumped in. From the outside it seemed the 
CDC. still might come up with a quick, easy explanation, 
and few big-time scientists would have been willing to 
switch to research that might prove a waste of time 

As a result the gap was filled by scientists who, like Dr 
lames Oleske of the New Jersey School of Medicme and 




BT HAtlY PINCUSFOt THE NIW RE PUS 



Denhstry ui Newark, stand below the top rung. Dr. 
Oleske, among the first to study AJDS m children, set off 
much of the current panic atxjut AIDS 

The mothers of most of the children who have AIDS are 
drug addicts, and other researchers had assumed that the 
children contracted the disease from their mother's blood 
m the womb. But Dr Oleske 
announced at a press confer- 
ence, m dozens of media inter- 
views, and. months later, in a 
paper in the journal of Ihe Ameri- 
can Medical Association that AIDS 
seemed to be spreading m the 
families bv casual contact, by in- 
haling the breath of a victim or 
by kissing. Several other soen- 
tists say Dr. Oleske's work is 
flawed (As Dr. Arye Ruben- 
stein, Professor of Pediatncs 
and Director of N . 1 . H research 
on AIDS at the Albert Einstein 
College of Medicine in the 
Bronx, diplomaticallv put it. 
"My feeling was that the infor- 
mation included in his JAMA 
paper does not yet gusHfy the 
(ar-reachmg conclusion that 
there is an intrafamilial spread 
through casual contact .") They 
contend he did not check thor- 
oughly enough whether the 
mothers had a history of drug 
use or bisexual lovers. Some of 
the cases, they say, might not 
have even been AIDS, and some 
were investigated after the vic- 
tims had died He was the 
first — and to my knowledge he 
remains the orJy — scientist to 
claim ttiat AIDS can be spread by 
casual contact. But a lot of re- 
porters picked up on that story. 
Soon hospital workers, prison 
guards, undertakers, and many 
others were regarding AJDS vic- 

bms as lepers 'V "y 

No group has suffered more u 
from bad science than Haitian 1 
immigrants When the first "* 
cases appeared. American doc- 
tors intprviewed the victims The doctors spoke mostly V 
English. Occasionally they found someone who could ask / 
the questions m French But the recent immigrants under- \ 
stand only a little French, and even less English None of 
the original interviews was conducted in their native Cre- 
ole. Nor did the doctors bother to learn much about the 
Haitian culture. They simply asked. "Are you a homosex- 
ual? Do you shoot drugs? " When the answer to both ques- 



AUCUST 1. I"(83 15 



26-097 O— 83- 



94 



bons was no, the doctors declared thai Haitians were sus- 
ceptible to AJDS for some myslenous reason. 

Sudder\ly there was a popular notion — and it seemed 
ever so logical — that AIDS had originated in Haiti What 
better place for a deadly new disease to spring up than the 
land of voodoo and poverty? And who better to blame 
than Haitian immigrants? Poor, black, and speaking little 
English, they were already facing more discrimination 
than almost any other group in America. So why not 
blame them for AIDS too? My experience at the airport 
illustrates the attitude about Haitians. About eighty Hai- 
tians in the United States — out of four hundred thou- 
sand — have AIDS. But because of the fear of AIDS, hun- 
dreds of immigrants have lost their jobs or have been told 
they will not get one. 

There is simply no evidence to support the soolled 
"Haitian connection." When Haitian doctors interviewed 
the victims, they learned that at least one quarter had 
worked as mate prostitutes meeting foreign gay men, 
mostly Americans, in ban in Port-au-Pnnce and in the 
resort areas of Cap Haitien. These Haitian men did not 
consider themselves homosexual. In fad, there is a strong 
cultural taboo against homosexuality in Haiti. Many of 
these men were married with families. They had sold 
themselves in order to survive. 

In Haiti 1 learned that AIDS is a growing problem there. 
At least one hundred fifty cases have Ijeen diagnosed But 
there is no evidence that AIDS began there. It probably 
came from the United States. In»Haiti many victims, like 
the victims among the immigrants to the United Stales, 
worked as male prostitutes. Others are their wives and 
girlfriends. Folk doctors, who provide much of the poor 
Haitians' medical care, often inject several patients with 
the same hypodermic needle without cleaning it. This 
practice may be spreading AJDS among Haitians the way it 
is spread among drug addicts in the US. Still, there is no 
reason to say that AIDS is a Haitian disease or that Haitians 
get it for reasons that are different from everyone else's. 

Some gay organizations and gay publications have re- 
peated the allegation that AJDS originated in Haiti. One 
story has it that during voodoo rituals Haitians drink pigs' 
blood, and can contract an African swine virus wfuch 
infects Haitian pigs. There is no evidence whatsoever to 
support this tale. Although gays have protested vocifer- 
ously about the discrimination they have suffered because 
of AJDS, some elements of the gay community seem to 
have no qualms about abetting discrimination against oth- 
ers. There is a strong desire among some gays to say that 
AIDS came from somewhere — anywhere — ebe. 

It is ui>likely we will ever learn where AIDS originated. 
Within a year or two scientists will probably identify a 
virus that causes it. But no one will be able to say where 
that virus underwent the genetic mutation that enaljles it 
to infect humans and destroy white blood cells We can 
say that once the virus appeared, one of the main reasons 
it became such a public health problem was the promiscu- 
ity of many gay men. 

Homosexuality, it has often been noted in the discus- 



sions of AIDS, IS as old as mankind Some people have 
always had sex with a lot of other people Bui the emer- 
gence of homosexuality as an accepted culture in the last 
decade enabled thousands of gay men to indulge in the 
age-old male fantasy of having sex with whomever you 
want as often as vou want. A network where thousands of 
people are interacting sexually is as rich an environment 
for the dissemination of I'isease as one could possibly 
imagine. This is particularly so when much of the sex is 
anal, wnth tiny sores in the rectum allowing for the mixing 
of semen and blood and often the blood of one sex partner 
with the blood of the other. 

Before AIDS appeared, many gav men were alreadv 
victim to dozens of tiactenal, viral, and parasitic infections 
which had been rare until recently. When a fatal disease 
found its way into the network, its rapid spread was 
inevitable — first among the most promiscuous, then 
throughout the gay community. Whenever it started, 
AJDS quickly became a disease of male homosexuals. More 
than 70 percent of the victims are gay men. The evidence 
suggests that from the homosexual matrix it spread to i.v. 
drug users, and then to the few dozen people who have 
gotten it from transfusions and to the few dozen 
hemopfiiliacs who have gotten it from Factor 8, a product 
made from blood which they must mject to make their 
own blood clot. Women who have contracted AIDS (the 
CD C. knows of 110 female victims in the United States) 
got it either from bisexual lovers or from dirty needles. 
The few dozen child victims almost certainly got it from 
their mother's blood while in^he womb and not from any 
casual contact. 

FACED with the possibility of contracting a fatal 
illness, many gay men have thought hard about their 
lifestyle. The issue has been raised frequently in gav 
publications. But even though gays have criticized 
government officials, most officials dealing with AIDS 
have tried not to sit in judgment on people's behavior — no 
matter how much that behavior may have been 
responsible for the spread of the disease. If AIDS were 
magicaDy to disappear and many gay men were to resume 
widespread promiscuity, there is a good chance that some 
other horrible disease would find its way mto the gay 
population and then spread to others. One need not be a 
Moral Majority moralist to raise questions about the fast 
life; there are powerful medical reasons for doing so, and 
for heterosexuals as well as homosexuals. (On July 2 |ay 
Mathews of The Washinj(ion Post, dting C.D.C. figures, 
reported significant declines in the numbers of cases of 
syphilis and gonorrhea since the beginning of the year. 
Several health officials speculate that the recent herpes 
scare has contributed to the decline.) 

In the past few months the N.IH. has responded. It has 
awarded millions of dollars in research grants, and some 
very good saentists have turned their attention to AIDS. It 
is now certam that glory awaits the one who discovers the 
cause of or cure for the disease. Scientists are using 
medicine's most complex and modem tecfinologies. It 



ALCLST 1. \<)»j i; 



95 



mav lake a few years, but il is a good bel they %vill 
succeed. 

But based on what is already known, and based on the 
behavior of viruses, parbcularly hepatitis B that aHects the 
same groups, it is possible to sort some things out now 

— Despite the hysteria, AIDS is not highly contagious 
All the evidence indicates it can be transmitted only by 
sexual contact or mixing of blood; even then it requires re- 
peated exposures. AIDS has been around long enough that 
if it could be caught by breathing the air or in some other 
casual way, there would be many cases. There are none. 
Thousands of gay men have had sex with AIDS victims and 
have not gotten it. A lot of people are waiting arwiously 
because the disease can appear six months to two years 
after exposure, but AJDS is certainly not anywhere nearly 
as contagious as the Black Death of the Middle Ages 

— There are more than seventeen hundred cases now, 
•nd theie will be mace than thirty-lour hundred six 
months from now But it is not likely there will be sixty- 
eight hundred a year from now Almost certainly, the 
number of cases is not going to double every six months 
as it has since the onset of the epidemic. At some point the 
disease %vill have swept through the susceptible 
populations and the number of new cases will level off 

— It is unlikely that everyone who is infected *vill get the 



fatal disease. Most viruses affect people to different de- 
grees It would be surprising if AIDS were different Some 
people ought get a "mild case" and act as carriers but not 
suffer the complete immune deficiency. 

— Another factor limiting the spread of AIDS is that 
while men can transmit it to women through sexual con- 
tact, there is little evidence that women can give it to men. 
Thus it will not spread like syphilis or gonorrhea 

— Finally, as long as AIDS receives close attention from 
the media there will be reports of people who contracted it 
through some route other than through sex, blood, or 
blood-contaminated needles. It is not easy to get honest 
answers about peoples' sex lives and drug-taking habits 

At the end of The Plague. Camus notes that the bacillus 
never really disappears, and reflects gloomily that "per- 
haps the day would come when it would rouse up its rats 
again and send them forth to die in a happy dty " His 
warning might apply equally well to Alt)S, because a mu- 
tant variant of the AIDS vims or some new organism could 
appear anytime. Even if mterferon, recombinant D N.A., 
or one of the other wonders of modem medicine provides 
a cure for AIDS or a vaccine to prevent it, health authorities 
and gay men would do well to remember the dangers to 
gays and others that a return to the old pattern of massive 
promiscuity would create. 



96 

Mr. Walker. Mr. Brownstein, I gather from your responses to 
some of the questions, and also what you said in your testimony, 
you see no evidence within the Public Health Service that there is 
a feeling among the CDC or the NIH scientists that hemophiliacs 
are expendable. 

Mr. Brownstein. No, but I would like to answer that more than 
yes or no. 

There was a comment made earlier about if this happened to 
Norwegians or tennis players, there would be a different response. 

Quite frankly, hemophiliacs do not represent any particular 
group that has been stigmatized or against which there has been 
discrimination; so we have received a very positive response from 
all the organizations we are dealing with. 

I am hearing, and I have heard, these other comments from 
other groups, from the other groups identified as being as high 
risk, and it has not been my experience, but, you know, there has 
never been discrimination on that basis, against hemophiliacs. 
There has been discrimination against hemophiliacs with respect to 
employment, and so on and so forth, being labeled as disabled, and 
so on, but not quite in the same regard. 

Mr. Walker. I appreciate your statement on that. 

Mr. Endean, you said it took the Federal Government 3 years to 
act on AIDS. Isn't it true that HHS officials dispatched epidemiolo- 
gists to New York City and California immediately after the first 
five cases were reported in Los Angeles in June of 1981? 

Mr. Endean. I can't speak to Los Angeles. 

I am not sure. My impression was that the epidemiological ef- 
forts that were underway were in New York City and not else- 
where around the country. 

Certainly all of us would have to agree that the epidemiological 
efforts to this point have been utterly and totally insufficient. 

Mr. Walker. Well, I am asking you to confirm the facts here. In 
other words, you don't have knowledge of the fact that the epidemi- 
ologists did begin acting after the first five cases were discussed. 
You don't have knowledge of that. 

Mr. Endean. Yes. 

Mr. Walker. Isn't it true the first AIDS victim was admitted to 
NIH in mid-1981? 

Mr. Endean. I can't speak to that. 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Weiss. Thank you very much, Mr. Walker. I want to thank 
our panelists for excellent testimony. 

Mr. Craig. The question of confidentiality is a very valid ques- 
tion. How are we to get the kind of information and material nec- 
essary. This question just came to mind, as you talk about national 
legislation to assure confidentiality and to gain the confidence of 
the people that that information would have to be sought from. 

Is there a problem with a national law versus State laws that 
say, certain types of behavior that these communities might be en- 
gaged in is an illegal type of behavior within the State confines, 
and therefore, the search for information, although the Federal law 
might blanket, they would run into the problem of violating State 
law? Is that a problem that anyone in this area has discussed? 



97 

Ms. Apuzzo. Sir, we are going to hear testimony from Lambda 
Legal Defense, which has coproposed this, and it sounds like one of 
those questions that we might best leave to the attorneys to define 
the parameters of. 

Mr. Craig. Thank you. Probably a valid suggestion. 

Mr. Weiss. Mr. Craig, thank you. 

Mr. McCandless? 

Mr. McCandless. In May of 1983, the French Government an- 
nounced its decision to ban the importation of American blood be- 
cause of its possible contamination with AIDS. 

We learned earlier that there is no test to determine whether or 
not blood has been donated by someone with AIDS before it is 
given as a transfusion. Is that correct? 

Mr. Brownstein. That is correct, and, in fact, at this point it has 
not been definitively established scientifically that it is a transmis- 
sible agent through the blood. 

Mr. McCandless. Is there any parallel between this and the 
problems we have had with hepatitis being transmitted through 
blood transfusions? 

Mr. Brownstein. I would defer to Dr. Bove, who will be testify- 
ing later this afternoon. 

Mr. McCandless. Do you know if we import blood for the pur- 
pose of creating the necessary activities to help the hemophiliacs? 

Mr. Brownstein. No, we do not import blood for that purpose. 

Most of the blood fractionation is done in the United States by 
four major pharmaceutical companies. In some small amounts, 
blood does come from European concerns. 

For the most part, the blood products that are used by hemophil- 
iacs are exported to other countries, and, in fact, the notion of bans 
on blood from the United States are somewhat overstated. 

I have just returned from the Congress of the World Federation 
of Hemophilia in Stockholm, and some of these reports are exag- 
gerated, and I would be pleased to elaborate more on that at some 
other time, if you wish. 

Mr. McCandless. Thank you, Mr. Chairman. 

Mr. Walker. Mr. Chairman, since there do seem to be some 
questions for the panelists, could we have permission to submit 
questions in writing to the witnesses, so we could have those to 
flesh out the record where some questions may still remain? 

Mr. Weiss. I am sure the panelists would have no objection to re- 
sponding to questions submitted in writing. 

Without objection, we will leave the record open for the 10 days 
after the close of the hearings for that purpose. 

Thank you all very much for very, very effective testimony. 

What has been demonstrated not just in your panel, but in the 
hearings up to this point, is that there is a tremendous lack of hard 
information about the Government's AIDS activities. That is what 
we are all struggling with. 

Thank you very, very much. 

The next panel includes professionals from the medical and re- 
search communities who have played critical roles in moving us 
closer to unraveling the puzzles of this devastating affliction. 



98 

I would like to call to the witness table Dr. Frederick Siegal, Dr. 
Mathilde Krim, Dr. Marcus Conant, Dr. Joseph Bove, and Dr. 
Bruce Voeller. 

While they are approaching the witness table, let me begin by 
introducing the panel. 

Dr. Marcus Conant, professor of dermatology at the University of 
California Medical Center at San Francisco, and president of the 
board of directors of the National AIDS-KS Foundation; 

Dr. Frederick Siegal, chief of the division of clinical immunology, 
at the Mount Sinai School of Medicine and City University of New 
York; 

Dr. Mathilde Krim, head of the Interferon Laboratory at Memo- 
rial Sloan-Kettering Cancer Center in New York, and chairperson 
of the board of trustees of the AIDS Medical Foundation in New 
York; 

Dr. Bruce Voeller, biologist, head of the Mariposa Foundation in 
Los Angeles. Dr. Voeller has held professorships at the Rockefeller 
Institute, Hunter College, and Harvard University; and 

Dr. Joseph Bove, professor of laboratory medicine, and director, 
blood transfusion service at Yale New Haven Hospital. Dr. Bove 
will be addressing the issue of AIDS and blood. 

I would appreciate it if you would stand at this point. Do you 
affirm to tell the truth, the whole truth, and nothing but the 
truth? 

Dr. Conant. I do. 

Dr. Siegal. I do. 

Dr. Voeller. I do. 

Dr. Krim. I do. 

Dr. Bove. I do. 

Mr. Weiss. Again, may I suggest that for the sake of time limita- 
tions, that you summarize your prepared statements. Of course, the 
entire text of your statement will be entered into the record. 

We will begin with Dr. Conant and proceed to Dr. Siegal, Dr. 
Krim, Dr. Voeller, and Dr. Bove. 

STATEMENT OF DR. MARCUS CONANT, PROFESSOR OF DERMA- 
TOLOGY, UNIVERSITY OF CALIFORNIA MEDICAL CENTER, SAN 
FRANCISCO, CALIF. 

Dr. Conant. Thank you, Mr. Chairman. 

Mr. Weiss. May I indicate for the benefit of the observers that 
we will take a brief break after this panel concludes its testimony 
and before questioning begins. 

Dr. Conant. I am Marcus Conant, codirector of the Kaposi Sarco- 
ma Clinic in San Francisco. 

We would like to thank you and the members of the committee 
for convening this hearing, and my complete testimony, as you in- 
dicated, has been submitted to your staff. 

I would like to, in my brief comments, focus in on just three as- 
pects of the problem as we see it as medical researchers involved 
with this problem in a community that has more per capita gay 
men than any other community in the United States. 



99 

Researchers who are in a major medical center right at the edge 
of that community, medical researchers who are seeing daily new 
cases of patients admitted with Kaposi sarcoma and Pneumocystis. 

The failure to respond to this epidemic now borders on a nation- 
al scandal. 

The second point is that this body, Congress, and indeed the 
American people, have been misled about the response. 

We have been led to believe that the response has been timely 
and that the response has been appropriate, and I would suggest to 
you that that is not correct. 

Finally, I would like to spend a few minutes from my perspective 
suggesting to you what needs to be done immediately, if we are not 
going to face a catastrophe of undeniably unbelievable proportions. 

First, the issue of failure to respond: I think that has created two 
major epidemics. The first epidemic is the epidemic of AIDS as we 
now know it, and the second is the epidemic of fear sweeping our 
country. 

There are now 1,900 cases of AIDS in this country, and 900 of 
those young people are dead. 

The epidemic is now doubling every 6 months. 

We hear that changes in lifestyle may make the problem go 
away. I would suggest to you that many members of the gay com- 
munity that I see as patients have clearly changed their lifestyles. 

If you were confronted by a disease that has a mortality rate ap- 
proaching 100 percent, it does not take much medical persuading to 
convince that patient to substantially alter his behavior, but I 
would further submit that to think that any individual is going to 
totally deny his sexuality, a basic human function, is naive and ex- 
treme. 

Gay men will continue to have sexual contacts. They will contin- 
ue, even though they know the risk that they are placing them- 
selves at; they will continue to be human. 

For us to suspect that they will cease to be human is naive. 

At this time 1 year ago, there were 300 cases of AIDS in the 
United States. We now have 300 cases of AIDS in San Francisco 
alone. 

By the time the current administration finishes its term of office 
iy2 years from now, there will be 12,800 cases of AIDS in this coun- 
try, and, as I have told you, 80 percent at least of those patients 
will die. 

No one who has acquired Pneumocystis pneumonia has survived 
for more than 2 years. 

Those brave young men that you saw testify are looking to you 
to help us to come up with treatments to try to prolong their lives, 
but at the present time no one with Pneumocystis has lived for 
more than 2 years after that diagnosis was made. 

If nothing is done by the time the next administration finishes 
its term of office, there may be as many as 3,300,000 cases of this 
disease in the land. 

I spoke of the epidemic of fear. In San Francisco, we now have 
the hysteria of policemen unwilling to go into certain areas with- 
out wearing masks, the ridiculous situation where a bus operator 
refused to take a transfer from someone he assumed might be gay, 
because he was afraid he would acquire the disease. 



100 

Clearly, we are failing in public education. The incredible situa- 
tion where nurses are refusing to care for dying patients because 
they don't understand enough about the disease, and they are fear- 
ful of acquiring the disease, themselves. 

We are failing in educating our medical community as well as 
the entire citizenry; and then we had a situation last week where 
young men were running through the streets of Seattle with ball 
bats, beating up on people who they think might be spreading a 
disease. These self-appointed public health officials out there 
spreading fear and anger, why? Because they are hearing this fear 
and anger from their parents and their peers, and it is our job to 
try to dispel some of that, and we can only do it with coordinated 
education at the highest levels. 

As a second point, I suggested that you have been misled; that 
we have all been misled. 

We heard a moment ago that the Government had only recently 
become aware of this problem. 

I was invited to attend the first meeting held at Bethesda, Na- 
tional Institutes of Health, in the fall of 1981. 

Everyone attending those meetings knew at that time what we 
were facing. We knew the type of disease we thought this was, a 
transmissible agent, probably blood-borne. 

We knew that the numbers were doubling at an incredible rate. 
We were terrified of the implications of this epidemic. We were at 
that time able to draw an epidemic coverage. 

By May 1982, we were predicting 300 cases by the end of 1982, 
And the prediction of that upsweep was perfectly correct. We were 
just naive in terms of the numbers. There were not 300 cases by 
the end of 1982, there were 900 cases. 

The delay in funding research has been unconscionable and has 
resulted in loss of lives. As a medical researcher I can tell you that 
we have lost much valuable information. Individuals who we could 
have questioned epidemiologically about who they had contact with 
are now dead. There is no way to do retrospective epidemiology on 
individuals who have died. By losing them we are losing informa- 
tion vital to understanding how this disease is transmitted. 

We know there are not enough projects yet being submitted by 
researchers across the country. And yet from our own institution, 
the full grant that we submitted was not fully funded. Many por- 
tions were completely approved. It went through the peer review 
process and we were told yes, indeed, this appears to be good work 
but there is not enough money to fund it. 

It would seem that the NIH does not have the money to fully 
fund all of the projects that have already been submitted, many of 
which are necessary and worthy. 

And I would suggest that there is a double accounting process 
going on. In terms that we have received in response to inquiries to 
the National Institutes of Health, we have been told that large 
amounts of money are being used to study and investigate the 
AIDS epidemic. And yet when we look at this, we find that these 
were moneys appropriated to study cancer, clearly appropriate 
studies that should go forward, but that were appropriated 4 and 6 
years ago. But they are now being lumped into the accounting for 
the moneys being spent for AIDS, deceiving, if you will, those read- 



101 

ing it into believing that this large amount of money is being spent 
on AIDS, when in fact there is nothing more than moneys that had 
been there all along for other important research activities. 

I would also like to focus on a misconception that we hear com- 
monly, that this is a problem often referred to similar to cancer 
where we may be in for the long haul. Let me remind this commit- 
tee that there are two aspects of this disease, and I think it is im- 
portant that all of us keep this clear. 

The first aspect is that we are dealing with a new sexually-trans- 
mitted blood-borne agent, probably a retrovirus, and that we have 
at our disposal the intellect, the abilities, the capabilities of isolat- 
ing a virus, producing a vaccine and protecting a population not 
yet exposed who are at risk. 

The second component of the disease is that in some way this 
agent mysteriously cuts off the immune system of its victims and 
places them at great risk for developing some opportunistic infec- 
tion, such as Pneumocystis pneumonia, or Kaposi's sarcoma. 

While it may take many, many years to unravel all of the im- 
munological complications of the disease, and by the time we have 
a vaccine we may have hundreds of thousands of people who have 
AIDS, who need that research to save their lives. Funds applied 
today to look for the agent may in fact break this chain of trans- 
mission. But the job is not easy. The incubation period of this dis- 
ease is 18 months. So if I put a vaccine in front of you today and 
we began to vaccinate individuals, that would have no impact on 
the incidence of this disease at all until 1985. 

Said another way, every case that is going to appear next year is 
already in the pipeline, and we have no way of stopping it. 

Namely, let me suggest some things at least from our perspective 
that could be done immediately and indeed must be done if we are 
going to prevent this disaster. 

First, new Federal funds need to be committed to attack specifi- 
cally this problem. Throughout this epidemic, some funds have 
been shifted from one agency over to another, a little bit of money 
has been found here, a small amount of money has been found 
there. The amounts of money for the type of problem we have here 
is just not adequate. 

I would suggest that you gentlemen view this like a national dis- 
aster, and if this city were devastated by a hurricane tomorrow, 
you certainly would not say, well, the sewage department is still 
working, the light departments are out there working, we are going 
to get the problem taken care of. The city would have been struck 
by a new disaster. And it takes new resources to deal with that dis- 
aster. 

This country has been struck by a new disaster. None of us ex- 
pected a new infectious disease to appear at the end of the 20th 
century which has a mortality rate greater than smallpox. We 
need new extensive funding to attack the problem. 

The second is that all of the worthy grants that have been re- 
viewed should be fully funded immediately, so that researchers can 
go to work to try to elucidate what the causative agent is and how 
it cuts off the immune system of its victims. 

The next thing is that the NIH should solicit grants frequently 
from the research community. There should be every 3 to 4 months 



102 

calls for new research papers to stimulate thought in the medical 
community and to continue to have new grants to review. 

The problem is changing rapidly. We need new information rap- 
idly. 

We need a task force in the executive branch of Government to 
attempt to coordinate the educational activities, the physician edu- 
cation activities, the community ne«^:'S that you had eloquently ex- 
pressed by the panel that preceded me. 

And finally, and probably the most important from the perspec- 
tive of a medical researcher, is we need an ad hoc peer review com- 
mittee, probably under the National Institutes of Health, which 
can expedite the peer review process. 

As a scientist, I can tell you that the peer review process is time- 
honored and worthy, and should not be tampered with except in 
the case of a national emergency. We have such an emergency 
today. Eminent scientists could be picked, they could review proj- 
ects, and they could recommend funding immediately. 

If the Jonas Salk of this epidemic were to appear today with a 
proposal that all of us felt was worthy, it would take him 18 
months to 2 years to get his first test tube paid for. 

For those of us from the west coast, we don't get back to Wash- 
ington very often. I was lucky enough to arrive 2 days ago, park 
and walk up the Mall, look at some of the national monuments 
that we don't get to see, and walked into the National Archives 
Building to see the Declaration of Independence. And one is struck 
that 207 years ago, when Jefferson penned that document, he said 
that we as citizens had three inalienable rights, and I don't think it 
is by accident that he said that the first of those was life. And he 
pointed out that to secure those rights, governments are instituted 
among men. And as I read that, it was his interpretation that the 
purpose of government, the mandate of government is to insure the 
life and lives of its citizens. 

We are in the beginning, not the midst — we are in the beginning 
of a national and indeed worldwide epidemic that is going to 
threaten the lives of hundreds of thousands of individuals. It would 
seem clear that the mandate of this Government is to respond and 
to respond immediately. 

Thank you, Mr. Chairman. 

Mr. Weiss. Thank you. 

[The prepared statement of Dr. Conant follows:] 



103 



My name xs Marcus A. Conant. I am a physician at the University 
o-f California at San Francisco and the co-director o-f its taposi 
sarcoma Clinic. I msh to thank Representative Weiss -for calling this 
hear i ng. 

some time three or four years ago. in a manner that will probably 
forever remain unknown, a new and terrifying illness was introduced 

copulation. At first, we did not even know that it had 



into the human popt 
arrived. Instead, it was thought that for some bizarre reason there was 
an epidemic of a rare skin cancer called kaposi Sarcoma among 
homosexual men in a few large cities. At about the same time, it was 
also noted that others in the sa^me population group were comma do^.n 
with a lethal form of pneumonia in unusually large numbers. It was not 
until several months later that public health officials realized th.^t 
the Illnesses they were seeing were actually only the symptoms of .> 
much more fearsome disease, the phenomenon we have come to call 
Acqu.red Immune Deficiency Syndrome. AIDS has since become America's 
most feared acronym. The statistics on its proliferation have become 
numbing, but they bear repeating here. Last year, there were a few 
hundred persons with AIDS. Now there are 1.300. The numbe." o- AIDS 
victims currently doubles every si. months, and by the end of the year, 
more than 3,000 people will have it. As the number of persons with AIDC 
grows, the growth rate of the disease itself also increases, with the 
AIDS population expected to be doubling first every four months, and 
then every two. The number of people with AIDS could easily reach t^e 
tens of thousands in the very near future. Because the incubation 
period for AIDS is so long- we believe it to be IB months- even if . 



-1- 



104 



vaccine were -found today, the number of victims would continue to grow 
until at least 1985. The final statistic in this grim litany is that 
nearly 60 percent of the people who contract ftlDS die from it. The 
disease, quite simply, is the most lethal infectiuous killer known to 
modern medicine, and it is on a. rampage in this country. 

In the face of this appalling specter, one would expect the 
government of the United States, the world's most affluent and 
technically advanced nation, to be sparing no resource in its fight to 
stop AIDS. But as a physician and res-B^rcher who has worked with this 
problem from the beginning, I have to characterize the federal 
response to AIDC as bordering on the negligent. I see in my office 
every day young men who shiould be in the prime of life but iiho instead 
are wasting away towards an early, pointless but once-preventable 
death. They regularly ask me why theii- own government does not seem to 
C3.re if they live or die. The question is not a rhetorical one. I ha'.e 
no answer for it 

I would like in my testimony to explain briefly how the federal 
response has been inadequate, and then to propose what I think we as a 
nation should be doing. 

Recently, the administration announced that conquering AIDS is, 
in the words of the Secretary of Health and Welfare, the nation's 
number one health priority. We welcome this verbal support, especially 
after such a long period of official silence. However, I wish it was 
'(>eing backed up with financial support as well. The record clearly 
shows that it is not. 

-2- 



105 



We o-ften hear that •from the National Institute of Health that it 
has all of the money it needs to deal with AIDS. However, my every 
experience with AIDS contradicts that. I can, witfi no effort at all, 
think of two dozen research projects that could be crucial to the fight 
against AIDS that aren't being carried out for the simple lad of grant 
money. I I now of any number of colleagues who, instead of staying in 
their laboratories doing vital research, have to spend their time 
chasing funds. Compared to the enormity of the problem, the federal 
funding response has been, relatively speaking, a pittance. The failure 
of the federal government and the NIH to respond pr'omptly and 
forcefully to this crisis is a tiational disgrace. It has helpt^d the 
spread of two epidemics, one of a deadly disease, the other of public 
hysteria. I cannot help but conclude that federal officials who say 
that enough money is being spent on AIDS are simply mouthing seme 
required political line that has nothing to do with reality. I wish 
they could be with me in my off ice. every day as I have to face yet 
another patient who will likely die because a major federal commitment 
to fighting AIDS was not made sooner. 

I would also question whether the federal government has actually 
committed as much money to this fight as it says it has. 1 believe that 
the NIH has been less that candid in describing the amount it is 
spending on AIDS. For e;:ample. the NIH includes in its figures monies 
it was spending on projects that have nothing di-ectly to do with AIDS; 
projects that wej-e underway before the AIDS epidemic even began. I also 
know that the National Cancer Institute has not released some of the 



106 



monies lor research projects that it has already approved through its 
laborious peer review process. It is almost as though dubious 
accounting methods are being used to inflate the -federal government's 
purported AIDS budget in order to create the appearance of a major 
effort being undertaken, when in fact that is not the case. 

The United States can be proud that its research establishment is 
the ablest in the world. It stands ready to be unleashed against AIDS? 
all that is needed is the backing of the federal government. The 
tremendous intellectual resources of the public sector, including 
private industries and the universities of America, must be utilized 
in solving this problem. This can only be accomplished if Congress 
appropriates enough money to stimulate research outside of the MIH anJ 
the Center for Disease Control. I am sure we all have different 
opinions about how active the federal government should be in matter-:; 
of social welfare. But no matter what your notion of the proper federal 
role is, it has to include taking the lead in a fight against a disease 
that has struck citizens in every state of the union; a fiqht that onlv 
the federal government has the resources to undertake. 

There is one point I would like to address here briefly before 
moving on. Most of my patients with AIDS ars gay, and almost to a man. 
they tell me that they believe the federal government would have acted 
against AIDS with a vengeance had it only struck a segnient of the 
population that was in better standing at the moment in the nation- s 
capitol. While gay men are by no means the only persons afflicted by 
AIDS, it is clear they have suffered from it more than any other group. 
I personally find it hard to believe that any member of Congress would 

-4- 



107 



deny -funds -for research into an disease because they did not approve of 
certain aspects o-f the li-festyles o-f most o-f the people contracting it. 
AIDS is a medical problem, and questions o-f the legitimacy or 
illegitimacy o-f the modern gay movement must be le-ft to some other 
-forum. But i-f anyone is reluctant to -fund the -fight against AIDS 
because most of its victims happen to be gay, let me lead them to the 
crib of a newborn child who has AIDS, so they can watch as the infant 
screams with pain. There alone they will find reason enough to want to 
halt this killer. 

One misconception frequently heard from funding agencies is that 
AIDS is such a complex, enigmatic pathological phenomenon that 
providing funds for research would be lite throwing money dovjn a 
bottomless hole. The analogy is sometimes drawn to cancer, where a 
final cure is probably still many ypars away. This is a grievousl'/ 
mistaken assumption, which if not corrected, could spell the deaths o "^ 
tens of thousands of Americans. 



AIDS is a baffling medical mystery. But it is a sgl.yeabl_e medical 
mystery. AIDS is a new infectiuous disease agent, and all asailable 
evidence indicates that it is some form of virus. Fortunately, at this 
point in the twentieth century, (thanks in no small part to the 
support for scientific research provided in the pi<st by tne Congress) 
we have the Inowledge and tools at our disposal to isolate a virus. We 
can then proceed to sequence the genetic ihforniation in the virus; to 
produce a vaccine that will protect people from acqui''ing the virus 
without incurring the disease; to clone that genetic material; and to 



108 



then produce large amounts o-f the vaccine -for public distribution. We 
are hope-ful that, given the proper support, we can accomplish all o-f 
this reasonably quickly, and thus break the chain o-f transiTii ssi on of 
this disease. 

But even with that achieved, there would remain another enormous 
medical and social problem connected with AIDS. By the time a vaccine 
is developed, there will likely be tens or hundreds of thousands of 
persons already afflicted with AIDS. In those cases, a vaccine would he 
useless, since the virus is already present in their bodies and 
wreaking havoc with their immune systen.s. We therefor need to continue, 
at fever pitch, research into the e>:act mechanism by which AIDE does 
its work. This is so we can save the lives of those already with tht 
disease, and the many more we know will be contracting it before thcf 
vaccine is available. 

These, then, are the two ultimate goals of AIDS research — 
creating a vaccine for the well and finding a course of treatment for 
the ill. How do we accomplish all of this? 

I would like to put forward the proposal that AIDS is such an 
unparalled threat to the American people that an emergency task force 
be created at the very highest level of government. The task force 
would be headed by an emergency coordinator whose job it would be to 
act as steward while we, as a nation, join together to fight this 
threat. The group would report directly to the President or to the 
Secretary of Health and Welfare. 



109 



There are dedicated men and women throughout the country mating 
heroic efforts every day to solve the AIDS mystery. I have nothing but 
respect -for my research colleagues at the NIH and the CDC. Without 
them, we would be crippled in this effort. But the work of those 
scientists, along with those at research centers throughout the 
country, is not being coordinated; it is as though they are along the 
rim of a wheel that has no center. A tasl force would be that center 
of the wheel. This is not some symbolic action or hollow public 
relations gesture, but a desparate need. Today, with no one group 
overseeing the entire AIDS effort, it is easy for research to be 
duplicated; for vital scientific findings not to be passed along to 
those needing them; for researchers in one part of the country to 
pursue leads already discredited somewhere else. As you can well guess, 
any of those scenarios can be deadly in such a time of crisis. Equally 
deadly is the busi ness-as-usual attitude of federal health officials in 
the timetables they use to approve funds for research studies. We 
desperately need to e;;pedite the funding of worthy projects. If the 
Jonas Salk of AIDS were to come to Washington today with a research 
proposal, he would probably be told to come back in two years after his 
papers had been reviewed. 

The National Conference of Mayors, at its recent annual 
conference, passed a resolution asl;ing the Congress to appropriate $50 
million a year to combat the AIDS threat. I think: that is an acceptable 
minimum amount. In considering the question of funding, the Congress 
must understand that AIDS is a new disease being visited on the 
population, and therefor new monies must be made available to deal with 



-7- 



26-097 O— 83 8 



no 



it. Some have suggested that AIDS research be funded by diverting money 
•from other public health projects. But it makes no more sense to do 
that than it does to find the money -for Social Security payments for a 
new retiree by cutting off payments to someone already in the system. 
The public health concerns towards which those earlier funds were 
appropriated &re still with us even with ftlDS, and they deserve 
continued federal support. As a researcher. I would also wish to point 
out that it would be extremely shortsighted to fund AIDS by cutting 
money that was earmarked for other, more basic, research. We iMOuld be 
helpless in the fight against AIDS — or in any othei- battle in 
medicine-- had it not been for the basic research done in years past. 
Continuing that research is part of our commitment to the future. 

I would lite to make one additional observation about money. I 
thini; it demeans this body to suggest that it would only male a 
judgE'ment on n.atters of life and death because of economics. The naiii 
reason we must vanquish AIDS is because it is the only moral choice 
presented to us. E'ut should anyone need further persuading, conside'' 
the simple dollars and cents of the matter. It now costs about *70,000 
to provide care for a patient with AIDS. Thousands have, ar will get, 
the disease. Simple multiplication makes it clear that it is cheaper 
for us to cure AIDS than to treat it. 

I have already spelled out the ultimate goals of AIDS research, 
and asked you to commit federal resources to help us achieve those 
goals. But there Are a number of other steps we must tale in the 
inter 1 m. 



-B- 



Ill 



«) While everything possible must be done to disseminate 
information about AIDS to all interested researchers, this must be 
done in such a way that patient confidentiality is preserved at the 
same time. Growing millions of Americans are completely comfortable 
with their homosexuality and do not regard i t as any source of 
embarrasment. But there are, of course, many others who are unwilling 
to be publicly identified as being gay. As a result, a firm federal 
policy on patient confidentiality would be a boon to research, since 
it would male closeted homosexuals much more willing to fully and 
candidly discuss their AIDS problems and related issues with their 
doctors. Such a policy would also respect the right to privacy that 
every American cherishes. 

«) We need to greatly expand the extramural research being done 
into the epidemiology of AIDS. The disease baffles us on a number of 
fronts, not the least of which is the networks by wh^ch it is 
transmitted. Some examples of the questions we would lite answered- Pan 
Francisco has a very large Asian population, yet there sre only four 
Asian-Americans there with AIDS, while most other ethnic groups have 
the illness in proportion to their percentage of the population. Why i£ 
this so? In the first sets of studies on AIDS patients, they were 
revealed frequently to be highly promiscuous gay men. This is not ai 
all the case today. Why the change? Among the Hatian males who have 
AIDS, nearly 100 have described themselves as hetrosexual s. How did 
the disease spread to them? The questions go on and on. 

*) Fundings for research proposals are generally reviewed through 

-9- 



112 



the peer review process of the National Institute o-f Health. This is a 
time-honored procedure, and one that all scientists, including myself, 
regard as the very cornerstone of our work. Truth flourishes and 
science advances only in an atmosphere of skepticism, questioning and 
caution. I think we must also remember, though, that we are in the 
middle of a public health emergency unlike any other of our 
generation, and that, as I indicated earlier, the slow, deliberative 
evaluations that in less critical times are the lifeblood of research 
could, in this instance, quite literally spell the death of untold 
thousands of Americans. In the average case, the time that elapses 
between a proposal being put before the NIH and the funds for the 
project being released is 18 months to two years. As I think you car. 
appreciate, that is close to an eternity when it comes to the current 
AIDS crisis. The NIH needs to very quickly establish an ad hoc review 
committee made up of able, dedicated e:;perts who can review propcsals 
for AIDS research on an emergency basis. These scientists would bring 
with them both their e;;pertise as researchers as well as their 
recognition that a grave public health crisis exists that demands 
prompt action. 

♦) I also think it is important for the NIH to issue a general 
call for research proposals dealing with AIDS. This would send a 
signal from the federal government to the scientific community that it 
is genuinely serious about AIDS. I know of a number of able scientists 
who currently will not even bother spending the time putting together 
an AIDS-related proposal because they feel it will not be seriously 
considering by the authorities in Washington. 



-10- 



113 



♦> Every American has an interest in seeing to it that the 
nation's blood supply is protected. Efforts must be made to develop a 
reliable, scientific method of screening that supply for infectiuous 
agents such as AIDS. In recent months, as it has become suspected that 
AIDS may be transmitted through blood transfusions, the vast majority 
of gay men have taken themselves out of the pool of blood donors for 
the duration of this health emergency. Most blood ban! s have also cut 
back on blood drives in gay neighborhoods. But a policy of protecting 
the blood supply by screening donors, rather than blood, is ultimately 
shortsighted and ineffective. It is easy to imagine, for example, an 
office blood bank drive where a closeted gay man, and a potential AIDS 
carrier, wishes to "prove" his hetrose;:ual i ty to his co-workers by 
going along with the others and donating blood. No amount of pre- 
donation screening or questioning can prevent a person like that from 
donating blood. And a massive screening effort to determine who is, 
and who is not, a homosexual (or, for that matter, an intravenous drug 
user or a Haitian or a hemophiliac) is a social policy that is, at 
very best, of questionable wisdom, and at worst Orwellian. As far as 
the nation's blood supply is concerned, the emphasis must therefor 
shift from the donor to the blood. 

♦) There needs to be increased federal support for persons 
actually afflicted with AIDS. The cost of AIDS treatment is 
staggering, and is simply beyond the financial resources of most 
Americans. In the case of kidney dialysis, the federal government long 
^go realized that it was not befitting a civilized nation for its 
citizens to die because they could not afford the cost of medical 

-11- 



114 



care. The situation is much the same today with AIDS, and I believe 
the federal response should be the same. 

«) Six months ago, those of us doing research into AIDS were 
■frightened by two things- the disease itself, and the complete lack of 
awareness of it outside of the gay community. Now, we have the opposite 
problem. There are, in fact, now two AIDS epidemics: one involving 
immunology, the other involving fear. There are any number of horror 
stories in this regard; one of the most appalling has to do with a San 
Francisco bus driver who, out of a fear of contracting AIDS from a 
tattered slip of paper, refused to take a bus transfer from a man he 
presumed to be a homosexual. I also hear too-frequent reports of 
hospital workers refusing to care for AIDS patients. It is a sad tims 
indeed when members of the healing professions no longer wish to car-? 
for the sick. 

I don't wish to belittle the fear'of AIDS; no one knows more tharc 
myself what a truly fearsome medical phenomenon it is. But I think 
there is a considerable public education project ahead of us to tell 
the public who is, and who is not, at risk. It cannot be repeated too 
often that there is no evidence that AIDS is transmitted through casual 
social contact. Common sense alone would lead one to that conclusion. 
If AIDS were easily transmitted, then by now millions of Aniericans 
would have it, not 1,800, most of whom 3.re gay men. 

In several ways, this fear of AIDS is a public health problem in 
its own right. The health and welfare department's new toll-free phone 



-12- 



115 



line IS a small step in the right direction. <I would point out, 
though, that the phone lines are receiving up to 10,000 calls a day- 
testimony indeed to the concerns Americans have about AIDS.) There are 
also grave questions o-f social justice in this regard. I have heard 
too many stories o-f persons with AIDS being fired -from their jobs or 
evicted from their homes once their condition became known. There are 
also economic aspects to the AIDS hysteria. My businessmen friends 
bad in San Francisco have started to worry about the effect of the 
fear of AIDS on tourism in that city. They also say that friends in 
other big cities have started to echo the same concern. There i= even 
the worry that foreign tourism to the U.S. could begin to suffer 
because of the world-wide attention given to AIDS. All of these AIDS- 
related fears ars, of course, groundless. A high-level task force cculr' 
do much towards re-assuring the public of that fact. 

*) The definition of AIDS must be broadened by the Social 
Security Administration for the purposes of providing benefits. 
Currently, the Social Security use the definition provided by the 
Center for Disease Control, which defines as AIDS patients as a person 
under 60 with either I aposi Sarcoma or Pneumocystis pneumonia, and ,=. 
few other disease, [^owever , we have recently see a number cf new 
infectiuous agents take hold in AIDS patients. These people are just 
as disabled, just as in need of Social Security help, as a person with 
KS. Yet they are currently denied that help because of an outdated 
definition of the problem. 

^, ♦) Due to the publicity AIDS has received in large cities with 
substantial gay populations, most physicians and other health care 

-13- 



116 



workers are now -familiar with the clinical mani -f estati ons of AIDS, as 
well as the appropriate treatment protocols. But this awareness of 
AIDS must be spread to doctors all over the country, so that persons 
suffering from the disease are diagnosed correctly, and from the very 
start receive appropriate medical care. This will help save the lives 
of these patients; it will also help curb the spread of the disease-. 

In closing, I would like to point out that last week: alone, my 
home city of San Francisco buried four of its sons; young men who onl/ 
months ago were in the prime of their lives. At a time such as this, 
one can't help but recall that it is the right to life that is 
the first of the three unalienable rights set forth in our Declaratior 
of Ir-idependence; and that, as Jefferson wrote 207 years ago, that it i r- 
tc secure those rights that governments are instituted among men. Any 
government has no higher purpose than to protect the lives of its 
citizens, and the citizens of the United States tooay face no greater 
public health threat than they do from AIDS. We havE the profound moral 
obligation to take every step necessary to c:onquer it as rapidly a= is 
humanly possible. 

Thank you. 



117 
Mr. Weiss. Dr. Siegal. 

STATEMENT OF DR. FREDERICK P, SIEGAL, CHIEF, DIVISION OF 
CLINICAL IMMUNOLOGY, MOUNT SINAI SCHOOL OF MEDICINE 
AND CITY UNIVERSITY OF NEW YORK 

Dr. Siegal. Mr. Chairman, I was asked to comment today on the 
response of the Federal Government to the public health emergen- 
cy presented by AIDS. I realized when thinking about this question 
that by virtue of existing NIH support, that I and many other in- 
vestigators like me do in fact represent a part, albeit small, of that 
response, and that to some extent my professional history and cur- 
rent work exemplifies some of what the Federal Government can 
do and is doing about AIDS. 

From my medical student days, through my house staff training, 
I learned in an environment heavily endowed one way or another 
by public support. But, and this is important, it was a time in 
which students and trainees were actively encouraged to enter a 
research career. The U.S. Army taught me practical public health 
and preventive medicine and Federal funds made possible the func- 
tioning of the immunology research laboratories in which I did my 
post-doctoral fellowship. 

Since 1973 I have been engaged in clinical investigation into the 
somewhat arcane and certainly obscure field of immune deficien- 
cies of adults, funded almost continuously out of Federal moneys, 
first at Memorial Sloan-Kettering Cancer Center and then Mount 
Sinai School of Medicine. 

It was not an endeavor that could have supported a private prac- 
tice. Yet from my relatively few patients with these rare diseases, I 
was able to have an impact chiefly because of my special research 
and rather unique background. 

I could not have predicted nor could anyone else that that kind 
of background developed first in 1970 could have had an impor- 
tance or usefulness to a major public health problem in 1983. 

At several other centers in New York City, as well as in Los An- 
geles, San Francisco, Atlanta, and Miami, physicians with similar 
backgrounds were also trying to figure out obscure immunodefi- 
ciencies. We were doing this for a variety of reasons, none of which 
obviously had anything to do with the coming epidemic, to help 
those few patients, to expand our own knowledge of those diseases, 
and to improve through those experiments of nature the under- 
standing of human immune deficiency infection. So we happened to 
be in the path of AIDS when it appeared and we were ready in 
effect to deal with the problem. 

Had the disease hit other cities in the United States, there are 
federally trained and supported clinical investigators who could 
also have promptly become involved. 

But given the present climate of opinion, we are concerned that 
10 years from now there won't be the same kind of background 
population available to study a similar epidemic. 

It might be useful to look back at the time of the outbreak of 
AIDS and the mechanisms that we did use to respond to it. 

In June 1980, the first of our cases appeared at Mount Sinai. He 
was then just an unusual case of immune deficiency, and we 



118 

turned our NIH-funded laboratory to his investigation. Because he 
had unremitting herpes simplex infection, we turned for help to 
colleagues at Memorial Sloan-Kettering, who had somewhat differ- 
ent and specialized backgrounds. 

Carlos Lopez, Ph. D., whose training in herpes viruses and the 
host defense was also supported by Federal grants, was also 
brought to bear on the problem as were many other investigators. 
Without realizing it, we had begun a prospective study of AIDS 
with our very first patient. 

[Article relating to study follows:] 



119 



%^ 



Vol. JOS No. 24 




j^^,/oj9S/ 



ULCERATIVE HERPES — SIEGAL ET AL. 



1439 



SEVERE ACQUIRED IMMUNODEnCffiNCY IN MALE HOMOSEXUALS, MANIFESTED BY 
CHRONIC PERLiNAL ULCERATIVE HERPES SIMPLEX LESIONS 

Frederick P. Siegal, M.D., Caru)s Lopez, Ph.D., Glenn S. Hammer, M.D., Arthur E. Brown, M.D., 

Stephen J. Kornfeld, M.D, Jonathan Gold, M.D., Joseph Hassett, M.D., Shalom Z. Hirschman, M.D., 

Charlotte Cunninoham-Rundles, M.D., Ph.D., Bernard R. Adelsbero, M.D., David M. Parham, M.D., 

Marta Siegal, M.A., Susanna Cunningham-Rundles, Ph.D., and DoN.t.LD Armstrong, M.D. 



Abstract Four homosexual men presented with 
gradually enlarging perianal ulcers, from which her- 
pes simplex virus was cultured. Each patient had a 
prolonged course characterized by weight loss, fever, 
and evidence of Infection by other opportunistic mi- 
croorganisms including cytomegalovirus, Pneumo- 
cystis carina, and Candida albicans. Three patients 
died; Kaposi's sarcoma developed in the fourth. All 
were found to have depressed cell-mediated immuni- 



ty, as evidenced by skin anergy, lymphopenia, and 
poor or absent responses to plant lectins and anti- 
gens in vitro. Natural-i<iller-cell activity directed 
against target cells Infected with herpes simplex virus 
was depressed in all patients. The absence of a histo- 
ry of recurrent Infections or of histologic evidence of 
lymphoproliferative or other neoplastic diseases sug- 
gests that the immune defects were acquired. (N Engl 
J Med. 1981; 305:1439-44.) 



CHRONIC ulcerating lesions caused by herpes 
simplex viruses (HSV) are unusual even in pa- 
tients with severe immunologic defects. These lesions 
occur in advanced lymphoproliferative disease, after 
immunosuppression for organ transplantation, during 
treatment with high doses of corticosteroids, and in 
certain primary immunodeficiency disorders.'"* In 
four previously healthy homosexual men we found 
chronic perianal ulcers infected with HSV. Immuno- 
logic evaluation confirmed the presence of apparently 
acquired cellular immunodeficiency. The course in 
these patients was characterized by severe, unrelent- 
ing opportunistic infections, leading to death in three 
patients. 

Methods 

8ub|«cts 

The four patients were referred to Mount Sinai Hospital or to 
Memorial Hospital for diagnosis or treatment. Controls were nor- 
mal male and female volunteers 20 to SO years old. 

Immunologic Studies 

Mononuclear cells were obtained from heparinized venous blood 
and characterized by cell markers as previously described.' Hy- 
bridoma-derived reagents defining Leu-1, present on all normal 
human T lymphocytes, and Leu-2a, characteristic of a suppres- 
sor/cytotoxic subset, were kindly provided by Dr. Robert L. 
Evans. '° Responses to phytohemagglutinin, concanavalin A, poke- 
weed mitogen, and alitigens from microbial pathogens were meas- 
ured by cellular DNA synthesis." Natural-killer-cell function was 
determined by comparing the cells* cytotoxicity among uninfected 
**Cr-labeled human-foreskin fibroblasts with their cytotoxicity 
among HSV-infected fibroblasts." Delayed skin hypersensitivity 
was tested with recall antigens that usually elictcd a respoiue in 
normal adults {Candida albuans, streptokinase-streptodomase, 
mumps, and tetanus toxoid). Immune complexes were detected 
with a modification of the Raji-cell assay for Patient 1 '* and precip- 
itation with 3.S per cent polyethylene glycol for the other three 



From the divisions of Clinical Immunology and Infectious Diseases, the 
Mount Sinai Medical Center, and the Clinical Immunology and Infectious 
'i>iBeases Services, Memorial Sloan-Kettering Cancer Center. New York. 
Uddrcsj reprint requests to Dr. Siegal at Mt. Sinai Medical Center. New 
*iOTk, NY 10029. 

' Supponed in part by granu (AI-16186 and CA-08748) from the U.S. Pub- 
lic Health Service, by the American Cancer Society, the Chemotherapy 
Foundation, and the Irma T. Hirschl Charitable Trust. 



patients." Specimens for viral culture were traruponed in Hanks' 
salts and incubated with a panel of cell types. Cytopathic effects in 
human embryonic kidney were observed within 24 to 48 hours when 
a specimen was positive for HSV. Commercial antiserums were 
used to characterize direct immunofluorescence for HSV in biopsy 
specimens. 



Patients 



PaUvnt 1 



A 26-year-old white homosexual man first noted perianal pain 
and vesiculation in January 1980. During the following spring, ul- 
cerations gradually developed and fever and weight loss began. At 
presentation elsewhere the patient was anemic. Results of marrow 
and liver biopsies were negative. Antibiotics were administered. A 
large perianal ulcer had formed by July, and hepatosplenomegaly 
and generalized lymphadenopathy were observed ivhen he was ad- 
mitted to Memorial Hospital. Cultures taken from the ulcer bed in- 
dicated HSV Type 2; sigmoidoscopy revealed proctitis and an an- 
terior artal ulcer. Chest x-ray films showed an infiltrate of the right 
upper lobe. Skin anergy was noted. Further evaluation for suspect- 
ed infiammatory bowel disease or lymphoma was negative. By Au- 
gust, the patient had lost approximately half his origiruU weight, 
and fever and perianal ulceration continued. Exploratory laparoto- 
my with splenectomy and biopsies of the Uver, small intestine, and 
lymph nodes showed only lymphocyte depletion. Satellite ulcers ap- 
peared on the buttocks. Parenteral nutritional supplements, trans- 
fusions, and antibiotics were given, but without benefit. In Octo- 
ber, the chest films were unchanged. Persistently positive cultures 
for HSV, abnormal liver-function tests, and an enlarging ulcer led 
to a trial of an experimental antiviral compound 2'-fiuoro,S-iodo- 
aracytosine (FIAC). Rectal bleeding developed; colonoscopy ir- 
vealed vesicles and ulcers, but biopsies were nondiagnostic and 
cultures were negative for HSV and other pathogens. Human-leu- 
kocyte interferon, broad-spectrum antibiotics, and trimetho- 
prim-sulfamethoxazole (TMP-SMZ) were given for increasing 
dyspnea with bilateral pulmonary infiltrates. Renal failure and en- 
cephalopathy developed, and the patient died in October. 

Autopsy revealed herpetic proctitis and colitis, with viral dissem- 
ination to the posterior colunuis of the spinal cord. Pntvmocystis can- 
mi was present in the lungs. Intranuclear and intracytoplasmic in- 
clusions typical of cytomegalovirus were present in the adrenals, 
limgs, colonic smooth muscle, and endothelium underlying the ul- 
ceratioru. Electron microscopy (kindly performed by Dr. Robert A. 
Erlandson) showed inclusions compatible with either HSV or cyto- 
megalovirus. 

Patient 2 

A 32-year-old Hispanic homosexual man had perianal vesicular 
lesions in July 1979; biopsy suggested cytomegalovirus infection. In 
November, he began to have fever, anorexia, gradual weight loss. 



120 



1440 



THE NEW ENGLAND JOURNAL OF MEDICINE 



Dec. 10, 1981 



abdominal pain, and hunatochezia. In March 1980, rectal bleed- 
ing was severe enough to require transfusion of eight units of blood. 
Ulceration of the perianal lesion and diffuse lymphadenopathy were 
noted. The cause of these conditions was not revealed by sigmoid- 
oscopy, gastrointestinal barium studies, examination of stools for 
bacteria and parasites, abdominal computerized tomography, so- 
nography, or serologic studies; on the basis of inclusions found on 
rectal biopsy, which suggested lymphogranuloma venereum, tetra- 
cycline was given, without effect. 

The patient was tratuferred to the Mount Sinai Hospital in May 
because of continued fevers and cachexia. He had oral candidiasis, 
generalized shotty lymphadenopathy, and abdominal tenderness in 
the left lower quadrant. The perianal ulcer had enlarged to 12 cm. 
Anemia and leukopenia were noted. Culture and immunofluores- 
cence testing of the ulcer showed only HSV Type 2. Evaluation for 
lues, gonorrhea, lymphogranuloma venereum, and other patho- 
geiu was negative. A biopsy suggested that HSV and cytomegalo- 
virus coexisted in the ulcer. Lymph-node biopsy indicated the ab- 
sence of germinal centers. Treatment with vidarabine for five days 
had no effect, nor did a four-day trial of acyclovir (kindly provided 
by Burroughs-Wellcome). Spiking fevers, rectal bleeding, progres- 
sive wasting and lymphopenia did not respond to broad-spectrttm 
antibiotics and transfusions. Terminally, the patient appeared to 
have a generalized cardiomyopathy; he died on August 8, 1980. 
Permission for autopsy was denied. 

Patient 3 

A 28-year-old Colombian homosexual man reported dull pain in 
the left lower abdominal quadrant and rectal bleeding in May 1 980. 
He was treated surgically for presumed perianal abscess. Postoper- 
ative rectal bleeding necessitated transfusions. In June fever (tem- 
perature to 40°C) and weight loss began. After additional anal 
surgery, a perianal ulcer developed and gradually spread. Tetracy- 
cline and prednisone were given. However, unrelenting fever, peri- 
anal ulceration, and a 12-kg weight loss prompted an extensive but 
unrevealing evaluation, which included colonoscopy, gastrointesti- 
nal contrast studies, marrow biopsy, gallium and liver/spleen 
scans, abdominal sonography, and standard cultures. 

The patient was transferred to the Mount Sinai Hospital in Feb- 
ruary 1981 because of cachexia and a 20-cm perianal ulcer (Fig. 1). 
Repeat evaluation for inflammatory bowel disease and lymphoma 
included exploratory laparotomy and construction of a diverting co- 
lostomy. No specific pathologic prtKess was found; node-biopsy 
specimens were normal. Cultures of the ulcer grew HSV Type 2, 
which was conTirmed by immunofluorescence testing and typical 
morphologic appearance. Vidarabine was given until ceniral-nerv- 
ous-system toxicity developed. In April, the patient was transferred 
to Memorial Hospital for further treatment with interferon and 
FIAC; however, the ulcer did not regress and cultures remained 
positive. Bilateral interstitial pneumonitis and encephalopathy led 
to his death in June. 

At autopsy, necrotizing, hemorrhagic bronchopneumonia, hem- 
orrhagic colitis, and cholelithiasis were found. Post-mortem cul- 
tures from lung, liver, spleen, lymph nodes, and heart were 
negative, but herpetic intranuclear inclusions suggestive of cyto- 
megalovirus were seen in the colon, adrenals, stomach, and lungs. 

Patient 4 

A 22-year-old Hispanic homosexual man had fever (38.5°C) and 
night sweats in July 1 980. Gradual weight loss began. Oral candi- 
diasis was noted in September. By December, an 8-kg weight loss, 
generalized lymphadenopathy, splenomegaly, anemia, and leuko- 
penia were observed. Chest films showed an infiltrate in the right 
upper lobe. Evaluation for underlying disease, including gastroin- 
testinal roentgenography, liver biopsy, gallium scanning, abdomi- 
nal sonography, and colonic and lymph-node biopsies, gave non- 
specific or normal results. In January 1981, perianal vesicular 
lesions first appeared; cultures showed HSV Type 2. Spiking fever, 
lethargy, anorexia, and weight loss continued, and the perianal le- 
sions formed a gradually enlarging ulcer; ulcerative lesions, from 
which HSV was cultured, also appeared on the nasolabial fold (Fig. 
2A). By April, the patient had lost 22 kg and had severe oral candi- 
diasis. Treatment with amphotericin led to some reduction in the 



candidal infection; klebsiella bacteremia resoWed with antibiotict. 
Treatment with vidarabine for two weeks did not affect the lesioi^ 
or other symptoms, but in May acyclovir (Burroughs-Wellcom*) 
given for 10 days led to defervescence and gradual healing of the 
ulcers (Fig. 2B). The marked lymphopenia and lymphoid dysfunc- 
tion that had characterized the disease (see Results) were not al- 
tered. TMP-SMZ was given in low doses to prevent pneumocys- 
tosis. In July, the ulcers recurred and HSV was again cultured. 
During successful retreatment with acyclovir, bluish nodules on the 
back and penile shaft were noted. On biopsy, a diagnosis of Kapo- 
si's sareoma was made. 

Results 

Serologic data are summarized in Table 1 . Patient 1 
never had detectable complement-fixing antibodies 
against HSV, Patients 2 and 4 had unchanging titers, 
and Patient 3 had a fourfold increment in titer. Sero- 
logic evidence of active cytomegalovirus infection was 
present only in Patient 2. Patient 4 had complement- 
fixing antibody titers of 1 .8 and less than 1 ;8. There 
was no evidence of acute or recent infection with vari- 
cella-zoster or Epstein-Barr viruses, lymphogranulo- 
ma venereum, or toxoplasmosis. Antibody to hepati- 
tis B virus was present in two patients, and hepatitis B 
surface antigenemia developed late in Patient 1. Other 
serologic studies, particularly in Patient 1, failed to 




Figure 1. Perianal Ulceration of Patient 3, before Therapy 

with Vidarabine. 

The appearance of the lesion did not change during or after 

this treatment. 



121 



Vol. 305 No. 24 



ULCERATIVE HERPES — SIEGAL ET AL. 



1441 





Figure 2. Nasolabial Lesion of Patient 4. 

Panel A shows lesion (completely obstructing both nares) 

before therapy with acyclovir, and Panel B shows healing 

three days after treatment. 



suggest infection with legionella species, cryptococco- 
sis, histoplasmosis, Entamoeba histolytica, toxoplas- 
ma, respiratory 'syncytial viruses, or rubeola virus. 
Serologic testing for syphilis was negative in all pa- 
tients. 

Skin anergy to recall antigens was present in all 
subjects (Table 2). Total lymphocyte counts were reg- 
ularly depressed. Except for a single determination 
(Patient 1, July 1980), counts did not exceed 1000 and 
averaged from 200 to 600. The severe lymphopenia 
limited the studies that could be done. The propor- 
tion of cells with T-cell characteristics ranged from 
normal to depressed in various determinations. The 

firoportion of sheep rosettes tended to be lower than 
he proportion of cells demonstrable with use of hy- 
oridoma-derived antibodies to T cells (anti-Leu-1). 
Although this finding suggests that a serum inhibitor 
of rosette formation was present, none was found in 
Patients 3 or 4. The proportion of T cells exhibiting a 



suppressor/cytotoxic cell phenotypc (Leu-2a) was in- 
creased in Patient 3 but not in Patients 2 or 4. Lym- 
phocyte responses to plant lectins were moderately di- 
minished in Patient 1, more severely so in Patients 2 
and 3, and progressively depressed in Patient 4. Only 
Patient 4 had a response to phytohemagglutinin that 
was within the normal range when he was first stud- 
ied. Responses to pokeweed mitogen were relatively 
preserved. In Patient 1, despite only moderate de- 
pression of mitogen-induced proliferation, transfor- 
mation responses to all antigens tested, including 
HSV and cytomegalovirus, were absent. 

Measurements of serum immunoglobulin and Im- 
munoelectrophoresis indicated polyclonal hyperim- 
munoglobulinemia, particularly of IgA. Despite this 
finding, serum antibody titers were generally low. The 
proportions of B cells were normal in all subjects. Ab- 
solute numbers of B cells, as well as of T cells, were 
depressed. 

We considered the results of the assay of natural- 
killer-cell function in two ways. ( 7) HSV-specific nat- 
ural-killer activity in lytic units per million mono- 
nuclear cells was determined directly from the lytic 
system. The calculation, which is based on a range of 
ratios of killer cells to target cells, considers all cells 
isolated from blood." According to this standard, nat- 
ural-killer activity was normal in Patients 1 and 4; it 
was initially very depressed, in Patient 3, but later 
gradually became normal. (2) Because of the severe 
deficiency of mononuclear cells, calculation of the 
lytic units per milliliter of blood, based on cell yields, 
was also made (Table 2). By this criterion, all sub- 
jects had severely depressed natural-killer function; 
Patient 2 had no measurable activity. 

Discussion 

Ulcerative lesions caused by HSV are usually ob- 
served only in patients with severe deficits of cellular 
immunity associated with another underlying dis- 
ease.'"' That four patients who were believed not to 
have been previously immunocompromised had such 
skin lesions (with three dying after an inexorably 
downhill course) suggests that some factor common to 
all the patients was operative. Tlie fact that all were 
homosexual men was striking. Reports of Kaposi's 
sarcoma and opportunistic infections similar to those 
that we observed (e.g., P. cannii, Cryptococcus tuofor- 
mans, and cytomegalovirus) suggest that our findings 
are part of a nationwide epidemic of immunodeficien- 
cy among male homosexuals."'" 

The most prominent and so-far unexplained im- 
munologic finding in these four men was profound 
lymphopenia. Many of the immunologic deficits that 
we measured could be attributed to this state of ap- 
parent lymphocyte depletion. Skin anergy was pres- 
ent in all subjects. When the responses to in vitro 
stimulation with plant lectins and antigens could be 
determined, they showed moderate to marked de- 
pressions in lymphocyte proliferative ability. Difficul- 
ty in interpretation of these data arises because of the 
paucity of available lymphoid cells and their dilution 



122 



1442 



THE NEW ENGLAND JOURNAL OF MEDICINE 



Dec. 10, 1981 



Table 1 . Evidence of Ulcerative Herpes Simplex and Other Infections among Four Homosexual Me.n. 



EvtDCNCl 










iKTicnoH* 






^ 




HSV 


CMV 


HBUK( 


HBlAb 


CadUc 


airtnU 


ADDWVnUS 


Enummii 
hUulyiUa 










fia o/patitmu fiutHw/iu 


■ uiai 






Pontive culture 


*/* 


0/4 


t 


t 


2/4 


t 


1/4 


t 


Morphologic (active infoctioa) 


*/* 


3/4 


t 


t 


2/4 


1/4 


1/4 


0/4 


Serologic 


















Prior exposure 


3/4 


2/4 


0/4 


2/4 


t 


t 


0/1 


1/4 


Active infection (titer rije) 


l/« 


1/4 t 


1/4 


0/4 


t 


t 


0/1 


0/4 



*HSV dcoolM herpes timpki vims, CMV cytomcfsioviius, HBsAg hepatitis B surfsce satigen, and HBsAb sntibody to HBaA«. 

tStiidy was either inappropriau or not performed. 

tAoother patieat (Patieot 4) had a cytomcfalovinjs titer bdow 1:8 oocompleaieatGMtioa when fiist studied; on a repeat study two weeks later the titer was 1:8. 



by monocytes in the mononuclear-cell isolates. Rela- 
tive monocytosis in mononuclear-cell preparations is 
known to lead to poor in vitro proliferative re- 
sponses." Among the lymphoid cells present, there 
was specific depression of cells forming sheep-eryth- 
rocyte rosettes in two patients and a relative rise in 
cells bearing the Leu-2a phenotype in one patient. 
The relative rise implies an increase in the ratio of 
suppressor to helper cells among the lymphoid-cell 
populations — a finding that we (unpublished data) 
and others'* have observed in cases of infectious 
mononucleosis. Attempts to rectify the lymphoid-cell 
responses of one patient in vitro by means of thymic 
humoral factors" were unsuccessful. When these find- 
ings were taken together, a severe defect in cellular 



immunity, which had been suspected on clinical 
grounds, was confirmed. The defect can be charac- 
terized as a progressive state of lymphocyte depletion 
and consequent dysfunction, in which cellular immu- 
nity is principally affected. 

The specific host defense against HSV is jjoorly 
understood. Although patients with depressed lym- 
phocyte counts or T-lymphocyte-macrophage dys- 
function tnight be expected to have severe illness sec- 
ondary to HSV, the vast njajority of such patients do 
not. Consequently, it is suspected that other factors 
play an important part in HSV-specific host defense. 
The group of patients most frequently reported to be 
susceptible to ulcerative HSV are those who have had 
immunosuppression for organ transplantation. Re- 



Table 2. Immunologic Findings In Patients and Controls. 



DeUyed-type skin response 


Abaent 


Abwnt 


Absent 




Abseat 








Praeal 


Mean lymphocyte count 


657 


435 


316 




360 








tOOO-4800 


T cells (pet cent) 




















Sheep rosettes 


70 


59,79 


28 




69.55 








80j:7 


Leu-1 


ND 


89 


S3 




65 








78±5 


Leu-2a 


ND 


20 


62 




29 








32±9 






















Phytohemagglutinin 


11,832 


1.509 


U13 


613 


23,100 


968 


475 


231 


29,00014,400 


Concanavalin A 


1.683 


1.767 


674 


386 


1,372 


767 


478 


576 


21,00016,200 


Pokewced mitogen 


S.63S 


1.148 


3.887 


766 


4,136 


1,067 


132 


589 


15.80015,100 


Antigen responses in vitro 


Absent 


QNS 


QNS 




QNS 








Positive 


Mixed leukocyte reaction 


1,50S 


QNS 


QNS 




QNS 








>5000 


(net cpm t) 
Natural killing of HS V- 


8J.I.4 





OJ-21.7 




15.7 








111(52-239) 


infected target cells t 




















Serum immunoglobtiUn 
(mg/dO 
■gO 




















864-1394 


2360 


1660 




1370-1710 








JOO-1500 


■SA 


322-375 


445 


435 




420-1431 








40-300 


IgM 


133-300 


90 


230 




55-275 








40-200 


Isohemagglutinin 




















Reciprocal 




















Titers (anti-A/B) 


-/8 


«/- 


32/8 




4/0 








>4 


B ceUs (per cent IgM-positive) 





QNS 


8 




8 








6±2 


Immune complexes 





0.20 


0.20 




0.04 


0.04 






<0.I2 



*ND denotd "not detenDioed," ud QNS "quantity not uifnaent [for detenninatioD)." 

TN«t cpm - (cpm stimulated) - (cpm ■■wtjiwi.twi cootrol), where cpm - couou (per miouu) of tritUted tbymidiM tooorponted after three dayi' cuhure (five days for mixed 
leukocyte reaction). 

tKillinf - (cytotoxicity toward infected tarfcu) - (cytotoxictty toward uninfected tar|ca), expreMed ■> lytic uniu per milliliter of blood. Normal ru«e - ±2 S.D. 00 loot-tno*' 
formed data." 



123 



Vol. 305 No. 24 



ULCERATIVE HERPES — SIEGAL ET AL. 



1443 



cently, cells that confer "natural" immunity and do 
not require prior exposure to their specific target cells 
have been described. Certain natural-killer cells are 
thought to be involved in the host defense against 
HSV in mice and in human beings."'^'' Overwhelm- 
ing disseminated HSV infection in neonates and in 
some adults is associated with depressed natural-kill- 
er activity of this sort." We measured this type of 
natural-killer cell in our patients because of their 
unusual HSV lesions. On a "per-cell" basis, the nat- 
ural-killer cells in two of the four patients were ab- 
normally hyporesponsive. Moreover, in view of the 
paucity of mononuclear cells present per unit of blood, 
the calculated herpes-directed natural-killer activity 
was severely depressed in all patients. Thus, a com- 
mon absence of HSV-directed natural-killer activity 
may be involved in the development of the ulcerative 
skin lesions. 

The cause of the immunodeficiency disorder that 
we observed is undoubtedly complex. Viral infection, 
especially in unusually heavy inoculum transmitted 
by enteric routes, may be an important initiating 
factor. 

Infection by a great many viruses such as measles or 
rubella can result in depressed delayed-type hyper- 
sensitivity.^' Primary cytomegalovirus infection has 
been associated with a particularly prolonged cellu- 
lar immuribdeficiency state."'" Exposure to cyto- 
megalovirus is known to be particularly heavy within 
the homosexual community; a 94 per cent prevalence 
has been defined by anticomplement immunofluores- 
cence." A series of four previously healthy homosexu- 
al men with active cytomegalovirus infections compli- 
cated by P. carinii pneumonia has been reported." In 
our series, disseminated cytomegalovirus was found at 
autopsy in Patients 1 and 3, and on biopsy and by 
seroconversion in Patient 2. Cytomegalovirus must be 
considered a candidate initiator of the immune de- 
fects observed. 

Serum immunoglobulins were increased. The con- 
sistent elevation of serum IgA levels could reflect the 
importance of gut-associated lymphoid tissue as a pri- 
mary site of immunization in this disorder. Battisto 
and Chase described a state of antigen-specific hypo- 
responsiveness occurring after oral immunization" 
that has recently been reported to result from the 
seeding of suppressor cells to non-gut-associated lym- 
phoid tissue." The immune deficit that we observed 
could likewise result, in part from the route of expo- 
sure to viral pathogens. 

Since these cases are certainly rare, even among 
homosexuals, additional factors must ht involved in 
susceptibility. A group may be specifically hypore- 
sponsive to HSV, perhaps because of their genetic 
background — e.g., HLA-D-linked immune-rc- 
■sponse genes. Heavy exposure to HSV could lead to 
xhronic infection, and secondary immunodeficiency 
could then result. At present, no group has been de- 
fined that is genetically susceptible to HSV. 

Still another possibility is that among men who are 
homosexual, some have a latent, broad-based cellular 



immunodeficiency that becomes clinically manifest 
only because of heavy exposure to certain pathogens 
in particular combinations. For example, a homosex- 
ual male nurse whom we studied recovered from 
Pneumocystis pneumonia but eventually died at 
another hospital of recurrent Pneumocystis and cyto- 
megalovirus pneumonia. He had markedly depressed 
cellular immunity in vitro and increased proportions 
of Leu-2a-positive cells among his T lymphocytes. Ex- 
tensive history taking by one of us (B.R.A.) indicated 
susceptibility to a variety of infectious agents over the 
previous 20 years, suggesting a low-grade cell- 
mediated immunodeficiency. 

Severe malnutrition probably accentuated the im- 
mune deficits that we observed." By the time these 
patients came under study, all were anorectic and 
cachectic and had been chronically ill for many 
months. Because of the specific immunosuppressive 
effects of zinc deficiency," plasma zinc levels were de- 
termined; they were found to be normal in all four pa- 
tients, but three were nevertheless given zinc salts em- 
pirically. In addition, efforts were made to improve 
overall protein-calorie intake through oral and paren- 
teral nutritional supplements. Neither of these ap- 
proaches seemed to alter the patients' clinical courses 
appreciably. 

In view of the relative preservation of immunologic 
functions early in the course of the illness in Patient 4, 
immu.ie deficits like those we observed appeared to be 
progressive with time. It seems possible that earlier 
recognition and prospective study of such patients will 
reveal an anomaly in host defense that could illumi- 
nate the pathogenesis of this disorder. 

There was no obvious contact between the four 
men. To ascertain whether there was any epidemio- 
logic relation among the viral strains isolated, we 
submitted samples of the viruses for restriction-endo- 
nuclease mapping" (by Dr. Bernard Roizman, Uni- 
versity of Chicago). The isolates, all Type 2, were 
found to be unrelated. 

We are indebted to Drs. Mark Chapman, Lawrence Ouiai, Bur- 
ton J. Lee, Jose Romeu, Donald T. Evans, and Mark Kunkel for al- 
lowing us to study their patients, and Drs. Jose Giron, Joseph 
Masci, and Roslyn Posner for their help in treating the patients. 



Note addtd in fmoj: We recently studied a fifth patient, a 45-year- 
old homosexual man with a nine-month history of hepatitis, gradu- 
al wasting, eventual intcrgluteal herpes simplex ulcers, and proba- 
ble herpes encephalitis. During the period of study, lymphoid 
function was initially normal, but it later deteriorated. Lymphope- 
nia developed only late in the course. Natural-killer-cell activity 
studied while the patient had normal lymphocyte counts was very 
depressed. 

Refebences 

1. Rawls WE. Herpes simpla vims. In: Ksplu AS, ed. The hetpesvi- 
ruies. New York: Acsdemic Press, 1973:291-325. 

2. Stroud GM. Recurrent herpes simplex aud steroid dosage. Arch Der- 
matol. 1961; 84:396-401. 

3. BeanSF.FusaroRM. Atypical cutaneous Herpes simplex infection •>■ 
tociated with acute myelogenous leukemia. Acta Derm Vcoereol 
(Stockh). 1969', 49:94-6. 

4. Logan WS, Tindall JP, Elson ML. Chronic cutaneous herpes simplex. 
Arch DermatoL 1971; 103:606-14. 



124 

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5. NUhimura K. Nagamolo A. Igarajhi M. Extensive skin manifesutionj mixed leukocyte culture responsiveness by adherent celU. Nature. 1976; 

of herpesvirus infection in an acute leukemic child. Pedialr. 1972; 260: 145-6. 



49:294-7. 



18. ReinhenE, O'Brien C.Rosenthal P.SchlossmanSF. The cellular basis 

6 Muller SA Herrmann EC Jr. Winkelmann RK. Herpa simplex for viral-induced immunodeficiency: analysU by monoclonal anUbod- 

infections m hematologic malignancies. Am J Med. 1972; 52:102- ies. J Immunol. 1980; 1251269-74. ,„„„,„.„„,„ , , 

iniecuons m ne g B ^^ ^^^^^ ^ p^^^^ ^ ^^^^ 1^^ ,^^f^ qj OReiUy RJ. Rauonale for 

8. --^:i!;rt^"^a^mai:^; ^^^li^tmen. w,.h acy- 20. ^^^^^. ^^ ^. ^T.^^^-""- 

9. Siegal FPUgG on infants' B lymphocytes; enhanced binding of IgG by on the function of the immune system. Annu Rev Microbiol. 1970; 
IgM-bearing lymphoid celU in early childhood. Scand J Immunol. 24:525-38. .„„ „ . „c oi i, ou u ™i, ms u~.l. 
1976- 5-721-9 22. Rinaldo CR Jr, Carney WP, Richter BS, Black PH, Hirsch MS. Mech- 

10 Evans RL. WaU DW. Platsoucas CD, et al. Ihymus-dependent mem- anisms of immunosuppression in cytomegaloviral mononucleosis. J In- 

brane antigens in man; inhibition of cell-mediated lympholysis by feet Dis. 1980; 141:488-95 ;„f^,„„ ,„j ,u, 

monoclonal antibodies to T„i antigen. Proc NaU Acad Sci USA. 23. ten Napel CHH, The HH_ Acute 'l'°'^?»'^°;^^^'''^°'"'l^ 

1981 78 544-8 ''°" immune response. II. RelaUonship of suppressed m viiro lympho- 

11. Oppinheim JJ,' Schecter B. Lymphocyte transformation. In: Rose NR, cyte reactivity to bacterial recall antigens and ™'08«ns with the devel- 
Friedman H. ^. Manual of clinical immunology. 2d ed. Washington, opment of cytomegalovirus-.nduced lymphocyte react.«ity. Clin Exp 
DC: American Society for Microbiology, 1980-.233-45. Immunol. 1980; 39:272-8. „^ ^ ^ ^, ^ „ „ ■.,.„,l„^„f„ 

12. Ching C, Lopez C. Natural killing of herpes simplex virus type l-in- 24. Drew WL, Mintz L, Mmer RC. Sands M Ketterer B P«v^">« f «>- 
fected target cells: normal human responses and influence of antiviral tomegalovirus infection m homosexual men. J Infect Uis. 1V81, 
antibody Infect Immun. 1979; 26:49-56. 143:188-92. ■ , „ _ 

13 Cunningham-Rundles C. Brandcis WE, Zacharczuk T, Good RA, Day 25. Battisto JR, Chase MW. Induced unresponsiveness to simple altegen- 
■ NK. Quantitation of circulating immune complexes in serum by Raji ic chemicals. II. Independence or<>''»y«<'-'yi« hyi«f«""<'"''');^"<' '<"■ 

celb using an enzyme-linked immunosorbent assay. Clin Exp Immu- mation of circulating antibody. J Exp Med. 1965; 121:591-606^ 

nol 1980-40:411-5. 26. Winchester RJ. Human and expenmental pathology. Theme 18 Sum- 

14 DigeonM LaverM, Riza J, Bach JF. Detection of circulating immune mary. Prog Immunol. 1980; 4:1263-6. 

complexes in human sera by simpUfied assays with polyethylene glycol. 27. Keusch GT. The effects of malnutnlion on host responses and the met- 

J Immunol Methods. 1977; 16:165-83. aboUc sequelae of infections. In: Grieco MH. ed. Infecuons in the ab- 

15 Gottlieb MS Schrotr R, Schanker HM, et al. Pneuitwcyslis carinii normal hos.. New York: Yorke Medical, 1980:210-30. 
pneumonia and mucocuUneous candidiasis in previously healthy 28. Oleske JM, Westphal ML, Shore S, Gorden D, Bogden JD, Nahmias 
homosexual men- evidence of a new severe acquired cellular immuno- A. Zinc therapy of depressed cellular unmunity in acrodermatilu en- 
deficiency N Engl J Med. 1981; 305:1425-31. teropathica: its correction. Am J Dis Child. 1979; 133:915-8. 

16 Kaposi's sarcoma and Pneumocystis pneumonia among homosexual 29. Buchman TG, Roizman B, Adams G, Stover BH. Restriction endonu- 
men — New York City and Cahfomia. Morbid Mortal Weekly Rep. clease fingerprinting of Herpes simplex virus DNA: a novel epidemio- 
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17. Berlinger NT, Lopez C, Good RA. Faciliution or atlentuation of 138:488-98. 

Dr. Siegal. Our laboratories, which in effect are extramural 
arms of the NIH, had begun to respond. And as the cases grew 
from two and then five, and as we heard from infectious disease 
specialists of other cases in New York, we turned the efforts of our 
laboratories from their originally intended projects to the problem 
of this peculiar new disease. 

By now, just among our group alone, unfortunately, we have al- 
ready studied more than 150 cases. Unfortunately, our studies have 
revealed a stereotyped pattern of progressive immunologic failure, 
with an unrelenting course that no one, as Dr. Conant has pointed 
out, has yet been able to reverse. 

Dr. Michael Gottlieb at UCLA, another federally funded young 
clinical investigator, deserves the credit for notifying CDC about 
the outbreak. He and his colleagues in Los Angeles were going 
through much the same process there as we were experiencing in 
New York. 

In the spring of 1981, we knew through the grapevine even 
before the June 1981 issue of Morbidity and Mortality Weekly 
Report what we had been clinically struggling with and puzzling 
over was a nationwide epidemic. 

By August that year CDC had officially reported HI cases of 
what we now call AIDS. 

As you have heard or will hear at these sessions, CDC from the 
outbreak committed itself vigorously to the problem, placing at the 
head of its task force on AIDS one of the most brilliant and com- 
mitted public health investigators I have ever had the privilege of 
knowing, Dr. James Curran. 



125 

I believe that the efforts of this team have been excellent and ap- 
propriate. But I understand that in order to carry out his mission 
in AIDS, CDC had to divert its already tight funds from other im- 
portant work. Symptomatic of the funding programs was the end of 
free distribution of Morbidity and Mortality Weekly Report, which 
many of us viewed as a setback for the dissemination of informa- 
tion on epidemic diseases and a disservice to public health in gen- 
eral. 

In March 1982, Dr. David Sencer, commissioner of health for the 
city of New York, convened the first of many monthly meetings for 
those involved in AIDS. Although some of us had research funds 
that were geared to indepth study of a few patients, they clearly 
were insufficient to deal with the citywide public health emergen- 
cy. There was no existing mechanism to quickly obtain support for 
a major effort to work out the epidemiology, etiology, immunology, 
and therapy of AIDS. 

On our behalf, Dr. Sencer requested Federal help in a letter of 
May 17, 1982, to Dr. Wyngaarden, Director of NIH, that I know to 
be available to this committee. 

Three months elapsed before the first RFA on AIDS was put out 
under which we first received funding on May 1, 1983, almost a 
year after Dr. Sencer's letter, and almost 2 years after the out- 
break had been officially reported by the CDC. 

I am told that this RFA had a shorter turnaround time than 
most as a result of efforts to facilitate peer review. While I whole- 
heartedly agree that careful critical peer review is essential, I be- 
lieve we must quickly work out how we can expedite it still further 
for the next public health emergency, especially if H.R. 2713 deal- 
ing with these crises should become funded. 

A delay of 1 to 2 years between the perception of a major prob- 
lem and its initial earmarked funding is unconscionably long. 

Despite a severe lack of allocated funds, things were not standing 
still in AIDS research between 1982 and early 1983. Many local in- 
vestigators did as we did, diverting their attention in research sup- 
port from other problems to this new one. The NIH became in- 
volved early, admitting cases for study to the Clinical Center, hold- 
ing meetings in Bethesda, and funding of these elsewhere. 

The FDA efforts too in basic investigation and in providing guid- 
ance for the improved safety of blood products should not be forgot- 
ten. 

All in all, I believe the Federal response to AIDS to have been 
excellent at the level of the CDC, although underfunded, but very 
slow and insufficient in delivering funds for specific basic research. 
The early gains in the disease such as its initial identification and 
characterization can be attributed largely to the long term public 
investment in academic tertiary care centers. 

This in turn depended on the past commitment to basic research 
and to the training of young people for biomedical education which 
flowered because of the foresight of those in the Congress who pro- 
vided the means. 

Many of us thought we had pretty much seen the end of infec- 
tious diseases as a major scourge of mankind. The tremendous suc- 
cess of antibiotics and now even of some antiviral agents has per- 
haps lulled us into an inappropriate sense of security. Consequent- 



26-097 0—83- 



126 

ly, we have lowered our research priorities in communicable dis- 
eases including those that are sexually transmitted. 

The National Institutes of Allergy and Infectious Diseases now 
lags behind the other institutes at NIH in its ability to fund ap- 
proved research applications even in areas directly germane to 
AIDS. In view of the likelihood that public health emergencies will 
involve infectious diseases, we cannot afford to neglect that insti- 
tute. 

Thank you for the opportunity to share my perspective with you, 
Mr. Chairman and Members of Congress. 

I will be happy to answer any of your questions. 

Mr. Weiss. Thank you very much. 

STATEMENT OF DR. MATHILDE KRIM, ASSOCIATE MEMBER, 
HEAD OF INTERFERON LABORATORY, SLOAN-KETTERING IN- 
STITUTE FOR CANCER RESEARCH, NEW YORK, N.Y. 

Dr. Krim. Mr. Chairman, my name is Mathilde Krim. I hold a 
Ph. D. degree and the position of associate member at the Sloan- 
Kettering Institute for Cancer Research in New York where I head 
the interferon laboratory. I have expertise in interferon research, 
virology, and, generally, in biology. Certain studies done in my lab- 
oratory complement those of the clinical investigators in our 
cancer center who explore the use of interferon preparations in the 
treatment of human disease, including Kaposi's sarcoma in pa- 
tients with the acquired immune deficiency syndrome. 

I am also the chairperson of the board of trustees of the recently- 
founded AIDS Medical Foundation. This Foundation was created 
by a group of collaborating investigators from several research in- 
stitutions who are actively engaged in laboratory and clinical re- 
search on AIDS. The Foundation's purpose is to conduct and fund 
research on AIDS. 

Its collaborative network was originally brought together by Dr. 
Joseph Sonnabend, of New York City. 

I am reading only parts of my testimony. 

Mr. Weiss. Your entire statement will be entered into the record. 

Dr. Krim. Yes, thank you. 

There are two things I would like to point out with regard to the 
Foundation, because they were mentioned earlier here. 

One is that we share with some of this morning's witnesses a 
great concern for the ethical problems raised by research with 
human subjects, particularly those afflicted with AIDS, since a 
large proportion of them are members of a minority which is still 
openly discriminated against in this country. Therefore, we have, 
as a Foundation, an interest in undertaking or supporting studies 
on the feasibility of devising protections which would not impede 
the provision of necessary data to legitimate research efforts but 
will do so only within the context of maximum protection for the 
identity and privacy of research subjects. 

We are also concerned by the ignorance about AIDS existing in 
the public, and very often among caregivers themselves, which re- 
sults in fear and, as a result of fears and uncertainty, there is prej- 
udice and in certain cases even hate. This sad situation has given 
rise, as we heard this morning, to incidents of discrimination 



127 

against a minority group. And if identity and privacy of patients is 
not protected carefully, it could result also in incidents of discrimi- 
nation against homosexuals. 

So to make up for this great need for accurate information our 
Foundation will also have a program on publication of medical and 
scientific advances translated into simple language for the public 
at large and nursing personnel in particular. 

Now, the substance of my testimony addresses two questions: 

Why should we as a society be concerned about AIDS and what 
should we ask the Government to do that it is not doing yet. 

The reasons for concern derive I believe from two considerations. 
One is humanitarian. The other one is a very pragmatic one, which 
breaks down into public health considerations and societal consid- 
erations. 

As for humanitarian considerations, they are based on the fact 
that AIDS has killed, after crippling and maiming for months on 
end, hundreds of mostly young, previously healthy, often highly 
gifted, productive people. It is paralyzing with fear hundreds of 
thousands, if not millions, more. The anguish it is causing is im- 
measurable. It can hardly be placated by words of reassurance in a 
situation of continuing ignorance of the cause or causes of the dis- 
ease, and of its precise mode of transmission. 

Epidemiological data suggests transmission from person-to-person 
through prolonged, intimate contact, which would seem to indicate 
that spread of the disease may not be very rapid. But in fact it is 
increasing, and the rate of increase has been close to doubling 
every 6 months. There are also lingering doubts that perhaps there 
can be transmission through a single blood transfusion, for exam- 
ple. 

Groups at risk are acutely aware of these uncertainties, and 
suffer great anguish from them. 

An aspect of the situation that goes largely unrecognized, al- 
though it contributes to its nightmarish quality, is that of the un- 
certainty of diagnosis. AIDS is an insidious disease with no clear 
onset. No single test has as yet become available that can unequiv- 
ocably diagnose AIDS before one of several life-threatening and 
usually uncontrollable infections makes diagnosis certain but, by 
then, futile. 

At that point in the disease it is too late for preventative meas- 
ures and, when the disease is fully established, also much too often 
too late for useful medical intervention. No treatment has yet 
proven to be life-saving. 

In about 40 percent of the patients a multifocal, uncontrolled 
proliferation of endothelial cells occurs under the skin and internal 
mucous membranes, which has been called Kaposi's sarcoma. This 
added complication is probably not a true malignancy, but it is 
highly visible, progressive and irreversible if treated unsuccessful- 
ly. AIDS patients also have a high incidence of true malignancies 
such as lymphomas, squamous cell carcinomas, and probably other 
cancers. 

Because the occurrence of an opportunistic infection and /or Ka- 
posi's sarcoma or cancer, on a background of severe cell-mediated 
immune deficiency, constitutes the only unquestionable diagnosis 
of AIDS, the disease has been defined on the basis of such a combi- 



128 

nation by the Centers for Disease Control. How and when the un- 
derlying immune deficiency becomes severe enough to allow for 
"CDC-AIDS" to develop is still anyone's guess. 

Many people from the general healthy population may present at 
times with transient but measurably deficient immune functions 
without suffering obvious ill effects. However, because of the lack 
of clear, early diagnostic criteria for AIDS, any immune function 
test that produces abnormal results in a male homosexual now 
spells terror. 

Physicians are at a loss to provide specific advice because they 
cannot tell if and when a deadly infection, Kaposi's sarcoma, or 
cancer are likely to strike, nor can they tell concerned individuals 
how to prevent this from happening. Immunodeficient gay men 
therefore live in a limbo, left to their own devices and private de- 
spair. 

There is today no effective, accepted treatment for CDC-AIDS, 
nor for Kaposi's sarcoma. A very high mortality rate is an undis- 
puted fact: a 40-percent death rate 1 year after diagnosis and an 
80-percent death rate after 2 years. 

I suggest that humanitarian concern is in order when a disease 
is so cruel and so severe that it kills so many and terrorizes so 
many more. Mere compassion should long ago have been sufficient 
reason for action. 

As for general public health considerations, the distinct possibil- 
ity still exists that the new infectious agents might be causally in- 
volved in AIDS. Such an agent might bo transmitted through blood 
and would undermine immune defense mechanisms important in 
the protection againt microorganisms causing opportunistic infec- 
tions, or against malignancies. Such an agent would not cause 
overt disease; rather, it would act slowly over a period of many 
months during which time the person infected by it might unknow- 
ingly be contagious. AIDS, with its dramatic late manifestations, 
would then only represent the end result of an insidious, much ear- 
lier infection with the hypothetical agent. 

Sociocultural factors, such as degree of sexual promiscuity, would 
then represent only a contributing factor which merely increases 
likelihood of viral transmission. Alternatively, environmental fac- 
tors favoring multiple infections with common microorganisms 
could predispose individuals to infection by a new, immunosuppres- 
sive viral agent. 

If one of these scenarios proves correct, there is truly no saying 
where the epidemic will stop. Some 24 infants have contracted 
AIDS or an AIDS-like disease and 18 have already died. More than 
100 women have contracted the disease, and most are dead. 

Are we witnessing the slow spreading of the disease beyond the 
neat high risk groups identified in early epidemiological surveys? If 
this may be so, can we indulge in the luxury of waiting to find out 
if this is so, when we know that months and perhaps years may 
have to elapse before the clearcut CDC-AIDS develops? 

Wouldn't the situation be sufficiently alarming to everyone to 
justify throwing the weight of the spectacular advances made in 
recent years in virology, molecular biology and immunology at the 
crucial question of whether or not a new virus, perhaps one related 
to the recently discovered human T-cell leukemia virus, is the real 



129 

culprit for AIDS? If such a virus were to be identified as the true 
cause of AIDS, vaccines could be produced and rational preventa- 
tive measures could be devised. 

I am concerned also about the societal consequences of AIDS. I 
think the preservation of hard-won civil liberties also calls for a 
rational, rapid and effective solution to the problems of AIDS. 

Words of reassurance sound hollow to many in the face of medi- 
cal ignorance of AIDS's causes, mode of spread, and effective treat- 
ment. Uncertainty breeds fear. AIDS may not only be destroying 
lives but also the very fabric of a humane and progressive society, 
on which this country prides itself. 

Couples have been torn apart, thousands of young men have 
been abandoned by family and friends, a minority group is victim- 
ized by incidents of gross prejudice leveled indiscriminately at its 
members. 

Our blood banks are in jeopardy. The whole blood banking 
system is in jeopardy in this country. Already scenarios for the 
quarantine of groups perceived to be "contagious" are emerging in 
thoughts, talk, and even writing. The atmosphere of doom and 
total helplessness surrounding the problem of AIDS threatens to 
push us back into a medieval society, complete with the equivalent 
of colonies of pariahs and lepers and, since homosexuality is not 
going to disappear from the face of this Earth, maybe we will also 
have colonies of "heretics" in hiding and an inquisition to find 
them out. 

What should we ask our Government to do in this situation? 

I believe that if there ever was a problem that cried for money to 
be thrown at it, AIDS is such a problem. Our biomedical research 
community is now suffering under recently imposed funding cuts 
which impede its healthy growth rate and, in many institutions, 
preclude its functioning at earlier levels of activity and excellence. 

On the other hand, extraordinary scientific advances have been 
made in recent years in the very areas pertinent to the solution of 
the problem of AIDS. A much better understanding has been 
gained of basic mechanisms of infection, immunity, cancer develop- 
ment and their biological control. This is putting into our hands 
powerful new tools for investigations of the etiology, diagnosis and 
treatment of infections and cancer. 

AIDS, a condition where all these pathologies are interrelated, 
can also be seen as an extraordinarily challenging "experiment of 
nature." If offered support for their studies, thousands of scientists 
could be enrolled virtually overnight to investigate every aspect of 
this intriguing condition. 

As for the areas of research to be supported, I believe that scien- 
tists will want to work in the following areas: They would like to 
conduct thorough extensive epidemiological studies going much 
beyond the necessarily early superficial studies carried out so far 
by the CDC, which are limited to this country. The epidemiology of 
AIDS should be studied in Africa, where the disease has been re- 
ported and in the Caribbean region, in Latin America, and in 
Europe. 

Epidemiological studies could precisely identify risk factors and 
thus make rational prevention possible. 



130 

Scientists would like to develop reliable diagnostic criteria for 
the disease. Only systematic prospective clinical studies involving 
many patients of both sexes, with different lifestyles and life his- 
tories, can result in a definition of clear predictive diagnostic crite- 
ria. Such studies are of utmost importance and urgency. They are, 
however, logistically and scientifically complex and therefore also 
costly. They are beyond the capability of any single clinic and labo- 
ratory, because they require expertise in multiple clinical and sci- 
entific disciplines. They would, however, allow rapid progress in ar- 
riving at an understanding of how AIDS develops, and they could 
also lead to accurate diagnosis, prognosis, and perhaps prevention. 

In this regard, I believe that the Government, in addition to 
funding, could help in planning and in offering resource support. 
This would be needed in the collection and storing of clinical speci- 
mens, their distribution to a variety of laboratories representing 
broad biological and immunological expertise, and the storage, re- 
trieval and analysis of a large number of laboratory epidemiolog- 
ical and clinical data. 

I believe that the areas of virology and immunology of AIDS 
must be the object of a host of studies that are needed as part of an 
intensive laboratory search for a possible viral etiological agent for 
which there is a suspicion but, for the moment no proof. 

Few clues exist as to which type of virus, if any, may be so in- 
volved. Until we know better, many viruses must each be suspected 
and investigated. Out of this research will also come the answer, 
for blood banks of how to identify infectious blood donations. 

A systematic study of the immunological abnormalities of AIDS 
patients must also be carried out: how these abnormalities develop 
in the course of time in various high at-risk groups, how they cor- 
relate with manifestations of viral and other infections, how they 
correlate with a patient's genetic constitution, history, and life- 
style. 

Again, these studies must involve many specialized laboratories, 
in order to cover the whole spectrum of specific and nonspecific im- 
munize functions that can be studied. 

The group of patients and controls studied in these biological and 
immunological respects, must be those followed clinically in the 
large prospective studies mentioned earlier. Such laboratory stud- 
ies will result in information on the etiology of AIDS and its diag- 
nosis, treatment and prevention. 

And lastly, we must develop methods of treatment. 

CDC-AIDS has so far been incurable. However, there are glim- 
mers of hope. Some have come from clinical trials with interferon 
alpha. Over half of the interferon-treated Kaposi's sarcoma pa- 
tients have not only seen their lesions regress or disappear com- 
pletely, but they have remained during treatment and for several 
months thereafter, up to some 2 years by now, free of deadly oppor- 
tunistic infections. They have even exhibited some favorable 
changes in their immune reactivity. Immunological improvement 
has not been seen following chemotherapy, although the latter has 
also been successful, sometimes, in making the lesions of Kaposi's 
sarcoma regress. 

Limited clinical trials of interferon alpha in Kaposi's sarcoma have 
so far been sponsored only by industrial companies that produce in- 



131 

terferon from recombinant bacteria and want to develop it as a 
commercial product, and probably also, on a few patients, by the 
National Cancer Institute. Trials have been limited to a handful of 
patients, their numbers having been determined principally by the 
companies' need for information to be provided to the Food and 
Drug Administration. 

In New York, to my knowledge, only one hospital, at the Memo- 
rial Sloan-Kettering Cancer Center, where I work, is involved in in- 
terferon trials with alpha interferon. The treatment remains un- 
available to most AIDS patients. 

I believe that the Food and Drug Administration should review 
the present evidence which comes from reputed clinical research 
centers in New York, in Bethesda and in California, and see wheth- 
er it is not sufficient to warrant the immediate provision by the 
NIH of interferon alpha to interested clinicians for the treatment 
of patients with Kaposi's sarcoma, foregoing requirements for 
double blind trials in the development of this form of therapy for 
this particular disease. 

Personally, I believe that, in the absence of any other effective 
and safe treatment, the present evidence of interferon's effective- 
ness should be considered sufficient to make this form of therapy 
immediately available to all those who may benefit from it. This 
should be done as early as possible following the appearance of Ka- 
posi's sarcoma lesions because this is a situation clearly favoring a 
response. 

I also believe that, at this point, not making interferon available 
now may literally amount to sentencing a substantial number of 
people to sure early death, because we know that Kaposi's sarcoma 
is a progressive, lethal disease and, it is clear that interferon can at 
least prolong life. 

Furthermore, interferon is not the only promising biological. In- 
terleukin 2, another product of human lymphoid cells, may also 
have immune-enhancing properties and it could potentiate interfer- 
on's effects in vivo as it does in vitro. Clinical trials of interleukin 2 
alone, and in combination with interferon therapy, appear war- 
ranted immediately. The exploration of other interferons, lympho- 
kines, and differentiation factors, alone and in combination, first in 
vitro and then in vivo, should be encouraged through grants from 
the Program of Biological Response Modifiers of the National 
Cancer Institute. 

These are but two areas in which immediate progress in therapy 
might be made. There are other approaches to therapy, both for 
the underlying immunological disease and its infectious and malig- 
nant complications. There is the use of plasmapheresis, there are 
methods to remove immunoglobulin complexes, there are methods 
to remove suppressor cells from the blood, there are certain drugs 
that are not immunosuppressive that could be tried either alone or 
in combination with interferon. 

Logistical and financial aspects to be considered in recommend- 
ing Government intervention: 

First of all, there is no lack of ideas in the scientific community 
on what to do about AIDS. I believe that the research needed can 
therefore be done almost exclusively through investigator-originat- 



132 

ed proposals in the form of individual research grants and/or col- 
laborative program projects. 

Central Government planning should be limited to helping with 
organizational and logistical problems in which the Government 
could be very useful in facilitating collaborations between experts 
in different disciplines. 

Our National Institutes of Health could, if directed to do so, set 
up mechanisms for fair and rapid allocation of funds and so avoid 
long delays— such as the usual 18 months— before funding. One or 
more ad hoc review committees could be appointed for the very 
purpose of reviewing and expediting the funding of projects in 
AIDS research The imagination, the talent and the ingenuity are 
there in the biomedical research community fully capable of ad- 
dressing the many scientific and medical challenges presented by 
AIDS. 

What is most needed from the Government is the money. And I 
don't mean money from the CDC or the NIH, that is, taken from 
Peter to pay Paul, which would cause internal disruptions, delays, 
and justifiable resentments. 

On top of already severe cuts suffered by the CDC in 1983, it is 
unrealistic and almost outrageous to expect this agency to do more 
now, in 1984, with a budget for its AIDS program that will be ex- 
actly $300,000 less than it was in 1983. Much the same can be said 
for the NIH. 

What is needed in the face of a national emergency is new 
money such as this country has always found whenever it has set 
itself to do a real job. 

How much money is needed? One way of calculating it is to take 
into account that the treatment of each CDC- AIDS patient is now 
well over $100,000 per year if he is treated properly. Since much of 
the treatment that can be offered is experimental, much of it is al- 
ready done at taxpayers' expense, through research grants, as we 
heard earlier from Dr. Siegal. 

Even if only half the present cost of treatment is borne by tax- 
payers, the bill amounts already to $100 million per year. And this 
covers only some 2,000 patients with CDC-AIDS with the frustrat- 
ing result of seeing them die anyway. 

The additional figures I think we must think of for a comprehen- 
sive program of research on AIDS must be of the same magnitude 
as the expenses we incur already. That is about $100 million. If 
roughly doubling the present financial burden imposed by the dis- 
ease may insure a resolution of the problem rather than permitting 
it to grow and fester as it does now, it seems clear that such an 
investment must be made. 

Finally, for those who may still feel that not enough people have 
died and that AIDS has not caused sufficient tragedy and anguish, 
let me end by stating that an appropriate investment in AIDS re- 
search will certainly benefit all of us in the long run, and in more 
than one way. 

Understanding AIDS will undoubtedly greatly improve our abili- 
ty to understand and therefore learn to control the biological 
events leading to acquired immune deficiency, susceptibility to in- 
fections and cancer in general. This will benefit infinitely larger 



133 

numbers of people than only those suffering from, or at risk of, 
AIDS itself. 

There can, therefore, only be winners in what I propose here. 

Gentlemen of the committee, there is therefore no reason and no 
excuse not to try and your decision should be very easy. 

Mr. Weiss. Thank you very much, Dr. Krim. 

[The prepared statement of Dr. Krim follows:] 



134 

Prepared Testimony of Mathilde Krim, Ph. D., Associate Member, Head, Inter- 
feron Laboratory, Sloan-Kettering Institute for Cancer Research, August 
1, 1983 

My name is Mathilde Krim. I hold a Ph.D. degree and the 
position of Associate Member at the Sloan-Kettering 
Institute for Cancer Research in New York where I head its 
Interferon Laboratory. I have expertise in interferon 
research, virology and, generally, in biology. Certain stu- 
dies done in my laboratory complement those of the clinical 
investigators in our Cancer Center who explore the use of 
interferon preparations in the treatment of human diseases, 
including Kaposi's sarcoma in patients with the acquired 
immune deficiency syndrome (AIDS). 

I am also the Chairperson of the Board of Trustees of the 
recently founded AIDS Medical Foundation. This Foundation 
was created by a group of collaborating investigators from 
several research institutions who are actively engaged in 
laboratory and clinical research on AIDS. We are studying, 
in a coordinated fashion, the same large group of patients 
and control subjects, and we exchange information on our 
respective results. 

This collaborative network was formed at the initiative 
of Dr. Joseph A. Sonnabend, himself a distinguished virolo- 
gist and interferon expert who has spent much of his pro- 
fessional life in academia. Dr. Sonnabend presently prac- 
tices medicine in downtown New York City. He was among the 
first physicians to observe cases of severe immunodeficiency 
and opportunistic infections among men living in the New 
York area. He became alarmed about it, since it appeared to 
be a new disease in this patient population, and he initiated 



135 



research into possible causes. Since no known animal model 
existed, research on the condition (later known as AIDS) had 
to be done on the patients themselves and/or on specimens of 
cells and body fluids obtained from them. Dr. Sonnabend 
enlisted the volunteer cooperation of his patients, deve- 
loped an informed consent form for their use, and at his own 
expense and through his own efforts, collected and distri- 
buted hundreds of specimens and relevant clinical infor- 
mation to several laboratories. His own earlier experience 
in academic research made him eminently capable of contri- 
buting to the planning of the research and the interpreta- 
tion of the results. A number of valuable publications by 
him and his collaborators resulted from these efforts. 

In late 1982, those investigators collaborating with Dr. 
Sonnabend all felt that they were making significant fin- 
dings, but all were facing great financial difficulties 
after several months of work without support. One of 
them--Dr. Michael Lange of St. Luke's Roosevelt Medical 
Center--obtai ned a grant in the amount of $22,400, which 
permitted him to continue his work. This grant did not come 
from the Federal Government but from the New York City's Gay 
Men's Health Crisis group. Unfortunately, the amount 
soon proved inadequate for the support of his increasing 
AIDS work load. By the fall of '82, Dr. Lange was studying 
over 150 men with different stages of the disease. At great 
expense, he was following them prospectively through a 



136 



battery of specialized tests administered to each patient 
every four months. 

By the spring of 1983, it was becoming clear that despite 
much talk of possible supplemental appropriations by 
Congress, no funding for AIDS research would be available 
for many months. Since most of us had already more than 
exhausted all resources available, including personal 
resources, we decided to form a public foundation in order 
to be able to continue our work through support solicited 
from private individuals, foundations and corporations. An 
announcement of the formation of the AIDS Medical Foundation 
was made on June 23rd, 1983. It was well received by the 
press. Comments of approval and encouragement were also 
received from many individuals. These were people from all 
walks of life. Some were patients or relatives of patients; 
others were motivated only by feelings of compassion and 
decency. This public response has been heartwarming. It 
augurs well for the Foundation's ability to accomplish its 
primarity goal, i.e. to keep alive the work of those 
investigators initially involved in its creation and even- 
tually to accept for review and funding other applications 
for AIDS-related projects. Without early support from the 
Foundation, many of these projects now face certain ter- 
mination. 

Foundation support will be wide open to any scientifically 
valid approach to the study of the new syndrome. 



137 



Selection of projects will be made--as for all Foundation- 
supported research--on the basis of scientific merit alone 
as determined by an impartial scientific peer review commit- 
tee. The Foundation has an interest in studies on indivi- 
duals from all high risk groups, including infants. 
Although the Foundation will concentrate on biomedical stu- 
dies, we are very mindful of the complex ethical problems 
that arise when research must be carried out on human sub- 
jects, particularly such as may be, or become, subject to 
public health reporting. Patient volunteers and the 
Foundation itself have serious and clearly legitimate con- 
cerns about possible breaches of privacy which might result 
in patient vulnerability to discriminatory practices. 
Discrimination against homosexuals can be, and indeed still 
is, practiced with impunity in many States of the Union and, 
in particular, in New York City. Therefore, the Foundation 
is also interested in undertaking or supporting studies on 
the feasibility of devising protections which, while not 
impeding the provision of necessary data to legitimate 
research efforts, will do so only within the context of 
maximal protection for the identity and privacy of research 
subjects . 

In addition, the Foundation is concerned about the con- 
sequences of irrational acts resulting from the fears bred 
by ignorance. Therefore, it has assigned staff to the task 
of translating evolving biological and medical knowledge of 



138 



the disease into language accessible to large audiences, 
specifically, patients, groups at risk and health personnel, 
The above describes my involvement in AIDS research and 
with the AIDS Medical Foundation, and hence, my presence 
here. 

I would now like to address two topics which will form 
the substance of my testimony. 

I. WHY SHOULD WE, AS A SOCIETY, BE CONCERNED ABOUT AIDS? 

Reasons for concern derive, I believe, both from humani 
tarian and pragmatic, health and societal, considerations. 

a. Humanitarian Considerations. 



AIDS has killed, after crippling and maiming for 
months on end, hundreds of mostly young, previously healthy, 
often highly gifted, productive people. It is paralyzing 
with fear hundreds of thousands, if not millions, more. The 
anguish it is causing is immeasurable. It can hardly be 
placated by words of reassurance in a situation of con- 
tinuing ignorance of the cause or causes of the disease, and 
of its precise mode of transmission. Epidemiological data 
suggests transmission from person to person through pro- 
longed, intimate contact. It does not preclude the possibi- 
lity of low level contagion through casual contact. In view 



139 



of the likely long incubation period and a few cases which 
have apparently resulted from blood transfusions or alleged 
casual contact, no one can say for sure, at this point in 
the history of this epidemic, how many may be just "at risk" 
and how many are already doomed. Groups "at risk" are acu- 
tely aware of these uncertainties and suffer great anguish. 

An aspect of the situation that goes largely unre- 
cognized, although it contributes to its nightmarish 
quality, is that of the uncertainty of diagnosis. AIDS is 
an insidious disease with no clear onset. No single test 
has as yet become available that can unequivocably diagnose 
AIDS before one of several life-threatening and usually 
uncontrollable infections makes diagnosis certain but, by 
then, futile. At that point in the disease, it is too late 
for preventative measures and, when the disease is fully 
established, also much too often too late for useful medical 
intervention. No treatment has yet proven to be life- 
saving. In about 40 per cent of the patients, a multifocal, 
uncontrolled proliferation of endothelial cells occurs under 
the skin and internal mucous membranes, which has been 
called Kaposi's sarcoma. This added complication is pro- 
bably not a true malignancy, but it is highly visible, 
progressive and irreversible if treated unsuccessfully. 
AIDS patients also have a high incidence of true malignan- 
cies such as lymphomas, squamous cell carcinomas and pro- 
bably other cancers. 



140 



Because the occurrence of an opportunistic infection 
and/or Kaposi's sarcoma or cancer, on a background of severe 
eel 1 -mediated immune deficiency, constitutes the only 
unquestionable diagnosis of AIDS, the disease has been 
defined on the basis of such a combination by the Centers 
for Disease Control (CDC). How and when the underlying 
immune deficiency becomes severe enough to allow for "CDC 
AIDS" to develop is still anyone's guess. Many people from 
the general "healthy" population may present at times with 
transient but measurably deficient immune functions without 
suffering obvious ill effects. However, because of the lack 
of clear, early diagnostic criteria for AIDS, any immune 
function test that produces abnormal results in a male homo- 
sexual now spells terror. Physicians are at a loss to pro- 
vide specific advice because they cannot tell if and when a 
deadly infection, Kaposi's sarcoma, or cancer are likely to 
strike; nor can they tell concerned individuals how to pre- 
vent this from happening. Immunodef i ci ent gay men therefore 
live in a limbo, left to their own devices and private 
despair. 

There is, today, no effective, accepted treatment for "CDC 
AIDS," nor for Kaposi's sarcoma. A very high mortality rate 
is an undisputed fact: a 40 per cent death rate 1 year after 
diagnosis and an 80 per cent death rate after 2 years. 

I suggest that humanitarian concern is in order when a 
disease is so cruel and so severe that it kills so many and 



141 



terrorizes so many more. Mere compassion should long ago 
have been sufficient reason for action. 

b . General Public Health Considerations 

If compassion is not sufficient justification for an 
immediate all-out national research effort, there are for 
all of us other, purely pragmatic and even selfish reasons 
forsuchaneffort. 

One such reason is simply that the distinct possibility 
still exists that a new infectious agent might be causally 
involved in AIDS. Such an agent might be transmitted 
through blood and would undermine immune defense mechanisms 
important in the protection against microorganisms causing 
opportunistic infections and malignancies. Such an agent 
would not cause overt disease; rather^ it would act slowly 
over a period of many months during which time the person 
infected by it might unknowingly be contagious. AIDS, with 
its dramatic late manifestations, would then only represent 
the end result of an insidious, much earlier infection with 
the hypothetical agent. Soci o-cul tu ra 1 factors, such as 
degree of sexual promiscuity, would then represent only a 
contributing factor which merely increases likelihood of 
viral transmission. Alternatively, environmental factors 
favoring multiple infections with common microorganisms 
could predispose individuals to infection by a new, immuno- 
suppressive viral agent. 



26-097 O— 83 10 



142 



If one of these scenarios proves correct, there is truly 
no saying where the epidemic will stop. Some 24 infants 
have contracted AIDS or an AIDS-like disease and 18 have 
already died. More than 100 women have contracted ths 
disease, and most are dead. Are we witnessing the slow 
spreading of the disease beyond the neat "high risk" groups 
identified in early epidemiological surveys? If this may be 
so, can we indulge in the luxury of waiting to find out if 
this j_s so, when we know that months and perhaps years may 
have to elapse before the clear-cut "CDC-AIDS" develops? 
Wouldn't the situation be sufficiently alarming to everyone 
to justify throwing the weight of the spectacular advances 
made in recent years in virology, molecular biology and 
immunology at the crucial question of whether or not a new 
virus (perhaps one related to the recently discovered human 
T-cell leukemia virus) is the real culprit for AIDS? If 
such a virus were to be identified as the true cause of 
AIDS, vaccines could be produced and rational preventative 
measures could be devised. 

c. Societal Considerations 



The preservation of hard-won civil liberties also calls 
for a rational, rapid and effective solution to the problems 
of AIDS. 

Words of reassurance sound hollow to many in the face of 
medical ignorance of AIDS' cause(s), mode of spread and 



143 



effective treatment. Uncertainty breeds fear. AIDS 
may not only be destroying lives but also the very fabric of 
a humane and progressive society, on which this country pri- 
des itself. Couples have been torn apart; thousands of 
young men have been abandoned by family and friends; a 
minority group is victimized by incidents of gross prejudice 
levelled indiscriminately at its members. Already scenarios 
for the quarantine of groups perceived to be "contagious" 
are emerging in thoughts, talk and even writing. The 
atmosphere of doom and total helplessness surrounding the 
problem of AIDS threatens to push us back into a medieval 
society complete with the equivalent of colonies of pariahs 
and lepers. 

II. WHAT SHOULD WE ASK OUR GOVERNMENT TO DO? 



If there ever was a problem in this country that cried 
for "money to be thrown at it," AIDS is such a problem. 
Our biomedical research community is now suffering under 
recently imposed funding cuts which impede its healthy growth 
rate and, in many institutions, preclude its functioning at 
earlier levels of activity and excellence. 

On the other hand, extraordinary scientific advances 
have been- made in recent years in the very areas pertinent 
to the solution of the problem of AIDS. A much better 
understanding has been gained of basic mechanisms oif infec- 
tion, immunity, cancer development and their biological 



144 



control. This is putting into our hands powerful new tools 
for investigations of the etiology, diagnosis and treatment 
of infections and cancers. AIDS, a condition where all 
these pathologies are interrelated, can also be seen as an 
extraordinarily challenging "experiment of nature." If 
offered support for their studies, thousands of scientists 
could be enrolled virtually overnight to investigate every 
aspect of this intriguing condition. 



A. Areas of Research to be Supported 

I believe scientists will want to work in the following areas 

( 1 ) Thorough, extensive epidemiological studies : 
These would expand the present efforts by the Centers for 
Disease Control to include other countries in Africa, the 
Carribbean region, Latin America and Europe. I would like 
to see such studies done by the CDC in collaboration with 
academic centers selected on the basis of their epidemiolo- 
gical expertise. Much could be learned about the cause(s) 
of AIDS and, if person to person spread occurs, about the 
mechanisms of transmission. Epidemiological studies could 
precisely identify risk factors and thus make rational pre- 
venti on possi bl e . 

(2) Developing reliable diagnostic criteria : Only 
systematic, prospective studies such as those now being 
carried out by Dr. Michael Lange and his colleagues will 



145 



lead to the definition of clear, predictive diagnostic cri- 
teria. Such studies are of utmost importance and urgency. 
They must involve large numbers of subjects, including men 
and women with different sexual preferences and life styles, 
all studied repeatedly through multiple tests, over a 
protracted period of time. Such studies are logistically 
and scientifically complex and therefore costly. They are 
beyond the capability of any single clinic and laboratory 
because they require expertise in multiple clinical and 
scientific disciplines. They would, however, insure rapid 
progress in arriving at an understanding of how AIDS deve- 
lops, and they could also lead to accurate diagnosis, 
prognosis and perhaps prevention. 

In addition to funding, government planning and resource 
support may be needed here for (a) the collection and 
storage of clinical specimens, (b) their distribution to a 
variety of laboratories representing broad vir.ological and 
immunological expertise, and (c) the storage, retrieval and 
analysis of a large number of laboratory, epidemiological 
and clinical data. 



(3) Virology and Immunology : A host of studies need to 
be done as part of an intensive laboratory search for a 
possible viral etiological agent. Few clues exist as to 
which type of virus, if any, may be so involved. Until we 
know better, many viruses must each be suspected and 



146 



appropriate efforts must be made to identify specific anti- 
bodies, viral antigens and viral genomes or genome fragments. 

A systematic study of the immunological abnormalities of 
AIDS patients must be also carried out: how they develop in the 
course of time, in various "at risk" groups; how they corre- 
late with manifestations of viral and other infections; how 
they correlate with the patient's genetic constitution, 
history and lifestyle. These studies must involve many spe- 
cialized laboratories in order to cover the whole spectrum 
of specific and non-specific immune functions that can be studied, 

The group of patients and controls studied in these 
respects must be those followed clinically in large prospec- 
tive studies mentioned above under "b." Such laboratory 
studies will result in information on the etiology of AIDS 
and therefore on its diagnosis, treatment and prevention. 

(4) Development of methods of treatment : "CDC-AIDS" 
has, so far, been incurable. However, glimmers of hope have 
come from clinical trials of interferon alpha. Over half of 
the interferon-treated Kaposi's sarcoma patients have not 
only seen their lesions regress or disappear completely, but 
they have remai ned--duri ng treatment and for months 
thereafter--f ree of deadly opportunistic infections. They 
have even exhibited some favorable changes in their immune 
reactivity. This has not been seen following chemotherapy, 
although the latter can also be effective in making Kaposi's 
sarcoma lesions regress. 



147 



Interferon trials in Kaposi's sarcoma have so far been 
sponsored only by industrial companies that produce infer- 
feron from recombinant bacteria and want to develop it as a 
commercial product. Trials have been limited so far to a 
handful of patients, their numbers having been determined 
principally by the companies' need for information to be 
provided to the Food 4 Drug Administration. In New York, 
only one hospital (at the Memorial SI oan-Ketteri ng Cancer 
Center) is involved in interferon alpha trials in Kaposi's 
sarcoma . 

I believe that the Food & Drug Administration should 
review the present evidence (which comes from reputed clini- 
cal research centers), and see whether it is not sufficient 
to warrant the immediate provision, by the NIH, of intar- 
feron to interested clinicians for the treatment of patients 
with Kaposi's sarcoma, foregoing requirements for double- 
blind trials in the development of this form of therapy for 
this particular disease. 

In the absence of any other effective and safe treat- 
ment, I personally believe that the present evidence of 
interferon's effectiveness should be considered sufficient to 
make this form of therapy immediately available to all those 
who may benefit from it. This should be done as early as 
possible following the appearance of Kaposi's sarcoma 
lesions, a situation clearly favoring a response. Not 
making interferon available now may literally amount to 



148 



sentencing a substantial number of people to sure, early 
death. It is clear that interferon can at least prolong 
life. 

Furthermore, interferon is not the only promising 
biological. Interleukin-2, another product of human 
lymphoid cells, may also have therapeutic immune-enhancing 
properties and may potentiate interferon's effects j_n vi vo 
as it does j_n vi tro . Clinical trials of interleukin-2 
alone, and in combination with interferon therapy, appear 
warranted immediately. The exploration of other inter- 
ferons, lymphokines and differentiation factors, alone and 
in combination, first j_n vi tro and then ji_n vivo , should be 
encouraged through grants from the Program of Biological 
Response Modifiers of the National Cancer Institute. These 
are but two areas in which immediate progress in therapy 
might be made. There are other approaches to therapy, both 
for the underlying disease and its complications. 

B . Logistical and Financial aspects . 

I believe that the research needed can be done 
almost exclusively through investigator-originated proposals 
(ROIs), in the form of individual research projects and 
collaborative program projects. Central, Government planning 
should be limited to organizational and logistical problems 
in which the Government could be very useful in facilitating 



149 



collaborations between experts in different disciplines. 
The imagination, the talent, and the ingenuity are out there 
in the biomedical research community, fully capable of 
addressing the many scientific and medical challenges of AIDS, 

Our National Institutes of Health could--if directed to 
do so--set up mechanisms for fair and rapid allocation of 
funds . 

What is most needed from the Government is the money ; 
"ot CDC or NIH money taken from Peter to pay Paul (which 
would cause internal disruptions, delays and justifiable 
resentments). On top of already severe cuts suffered by the 
CDC in 1983, it is unrealistic and almost outrageous to 
expect this agency to do more in 1984, with a budget for its 
AIDS program that will be $300,000 less than it was in 1983. 
Much the same can be said of the NIH. What we need is the 
new money this country can always find whenever it sets 
itself to do a real job . 



How much money is needed? The cost of treatment of each 
"CDC-AIDS" patient is now well over $100,000 per year. 
Since much of the treatment offered is experimental, much of 
it is done at taxpayers' expense. Even if one assumes that 
only half the treatment expenditures are borne by taxpayers, 
i.e. by the Government, the bill amounts already to $100 
millions per year. This covers only some 2,000 patients 



150 



with "CDC-AIDS", with the frustrating result of seeing them 
die anyway. 

The additional figures we must think of for a comprehen- 
sive program of research on AIDS must be of the same magni- 
tude. The total budget of a concerted, rational attack on 
AIDS through basic and clinical research must also be on the 
order of some $100 Million. If roughly doubling the present 
financial burden imposed by the disease may ensure a resolu- 
tion of the problem, rather than permitting it to grow and 
fester, it seems clear that such an investment should be 
made. 

Finally, for those who may still feel that not enough 
people have died, and that AIDS has not yet caused enough 
tragedy and anguish, let me end by stating that an 
appropriate investment in AIDS research will certainly bene- 
fit all of us in the long run, and in more than one way. 
Understanding AIDS will undoubtedly greatly improve our abi- 
lity to understand and therefore learn to control, the 
biological events leading to acquired immunodeficiency, 
susceptibility to infections and cancer in general. This 
will benefit infinitely larger numbers of people than those 
suffering from AIDS. There can, therefore, only be winners 
in what is proposed here. 



Gentlemen of the Committee, there is no excuse not to 
try and your decision should be easy. 



151 

Mr. Weiss. Again, the testimony that is being presented is ex- 
tremely important. Unhappily, we do have a time problem. The 
House is m session and the bells may go off at any time for votes. 
So I would urge you to try to summarize your presentations. 

Dr. Voeller. 

STATEMENT OF DR. BRUCE VOELLER, PRESIDENT, THE 
MARIPOSA EDUCATION AND RESEARCH FOUNDATION 

Dr. Voeller. First let me second the motions that my colleagues 
and predecessors have made thanking the committee for holding 
these hearings. I think they are of enormous importance, and the 
service being done is very great indeed, because the magnitude of 
the funding problem and the planning problem that exist goes far 
beyond what the public or governmental agencies have been aware 
of or certainly have publicized. 

Again, others before me have quoted the administration to the 
effect that their first order of priority is AIDS; that from the lead- 
ers of the Public Health Service and the HHS. I think that it is 
important to recognize that action does not jibe with HHS pro- 
claimed policy of "No. 1 priority." 

There have now been nearly 3 years where at least some of us, 
significant numbers of us, have been aware of the scope and seri- 
ousness of the problem of AIDS, and during that entire time the 
Centers for Disease Control, the NIH, and the Food and Drug Ad- 
ministration, and in larger form HHS, have not convened so much 
as a single large-scale national meeting of scientists and physicians 
from the private sector as well as of government to develop a com- 
prehensive master plan for discovering the cause of AIDS and for 
the developing of techniques for treating and preventing AIDS. 

To be sure, there have been small-scale limited-project commit- 
tees. Indeed Dr. Bove and I have served on two of those, dealing 
with AIDS and blood, at the invitation of those governmental agen- 
cies. But the fact remains that there has not been any major con- 
vening of people to discuss and develop an overall plan and in fact 
the truth is very simple, that there is no such master plan, and one 
is extraordinarily badly needed. 

That need is because of a whole array of things: 

First of all, we need to have an itemized list of all the conceiv- 
able kinds of research that could be done. You have heard by my 
predecessors today, a number of them, in the areas of immunology 
and virology and the like. 

We need to have more than anecdotal lists, we need comprehen- 
sive lists. We need to have lists which are prioritized, as well, so 
that popular scientific areas not be the only ones on those lists, and 
that things which may be much less generative of publicity, of 
which we have seen a great deal in the press over the past year 
and a half or two, be supplemented by ones that may be much 
slower to give results, much less likely to be aimed at Nobel Prizes 
or in major funds for the institutions supporting the people doing 
the research which has the publicity. 

We must not let those long-range projects lapse in favor of more 
popular conceptions. 



152 

We must, furthermore, have such a national master policy or 
plan for the purpose of peer review. The various branches of 
Health and Human Services, as you well know, have peer review 
for all manner of things considered an essential part of the fund 
granting process, and it absolutely needs to recognize that here, 
too, the Government can benefit from outside opinion, criticism, 
and honing of any master plan, and making sure of the things I 
have already mentioned as inclusions in it. 

Further, we have heard here today from various people the 
degree to which they are conducting individual projects. There is 
unwitting duplication; there is redundancy, because people do not 
know what the Government is planning or what others are up to. 
So we must have a master plan which can in fact let all of us know 
what the Government plans either to do, or through its resources 
to support others doing outside the Government. 

Finally, we need to be able to coordinate the roles the Govern- 
ment at the Federal level and State and city levels play. 

As you probably know. New York State and the city of San Fran- 
cisco have already allocated sizable funds for AIDS research and 
the State of California has funds pending. They need to be integrat- 
ed into the planning. We cannot afford the loss of time and pre- 
cious resources that will come from unwitting duplication, redun- 
dancy, and repetitiveness. 

It has to be said, I think very clearly, that there has been an 
overall lack of Federal leadership in this area, and that the re- 
search that has been done has been fragmented and ill-coordinated. 
Lacking a master plan, it should be obvious as well that no realis- 
tic budget can be devised. 

For the administration and the Congress to be considering small 
amounts of money, from my point of view, and from what you have 
heard from others who have testified here, creates an enormous 
problem. If you don't have a master plan, how can you produce a 
meaningful, valid budget? So it becomes obvious from that factor 
alone that a master plan is called for, needed, and wanted. 

And I will tell you that the size and amounts of the moneys that 
are being talked about are a drop in the bucket compared to what 
is really needed. If we look at only one or two examples, it will 
become evident. 

Take one, a smaller one actually. Interleukin 2 is reported to cost 
about $125,000 per patient to test at the NIH. Four people are 
being tested, a tiny number in terms of any kind of medical or sci- 
entific research for testing something that then would have to be 
used on masses of people. If we were to look at something on the 
order of 50 people at $125,000, we are talking already nearly half of 
the budget initially asked for by the administration in this country 
for all AIDS research — $14 million. 

Second, if we look at a far more costly example, one of the clear 
things that was mentioned earlier today as well was the need for 
an experimental animal model. In order to determine a cause — this 
is classic Koch's Postulates, which if you had any biological train- 
ing you learned in high school or in college medicine — you must 
first isolate what you think is the causal agent, then find a host to 
reintroduce it into to see if the host contracts the disease. We don't 
have an animal to test it in. 



153 

It is fine to believe this or that virus may cause AIDS. It is fine 
to carry out an array of immunological and virological studies. But 
at some point we have to go back and study whether or not the 
agent we believe is the causal agent is in fact the real one, before 
we go to the enormous cost and time-consuming process of develop- 
ing vaccines. 

I could not agree more with Dr. Conant, with what he had to say 
about working on prevention. We first need to know if we have 
identified the right beast before we do that. 

Well, most of the standard laboratory animals have been looked 
at. Things such as rabbits, rats, guinea pigs, et cetera, appear not 
to be susceptible to AIDS tissues or fluids from patients with AIDS. 
Consequently, we must move to the rather more time consuming, 
costly and difficult area of using primates. No one has a clue at 
this point whether any primate will be susceptible to AIDS. But 
what we do need to do immediately, because of the much greater 
medical affinity and physiological affinity of primates to human 
beings, is begin to look to see if any primate species is susceptible 
to human AIDS. Marmosets don't seem to be. 

I have calculated— and I won't go through all the figures here, 
inasmuch as they are in my written presentation to you— that if 
one looks at only six species of primates, and takes the relatively 
small number of 25 individual animals per species— and since we 
believe that AIDS has an average incubation of close to 2 years in 
human beings, and have no reason to suspect it would be particu- 
larly different among primates— if you multiply all those factors 
out, plus one extremely critical one from the Centers for Disease 
Control, a cost of approximately $100 a day per, animal to raise pri- 
mate animals for this kind of research, then you end up with a 
figure of almost $200 million merely to discover an animal which 
then can be used for tests. Such an animal could be used to deter- 
mine whether or not any of our short-term scientific tests have 
been effective in identifying a causal agent. We are then also more 
able to go forward to do the kind of logical step-by-step slow re- 
search which could lead to the isolation of a product or a virus or 
whatever may turn out to cause AIDS. 

Just to flesh that theoretical skeleton out a bit, if we think that 
blood may be the causal agent out of an array of things which 
might cause, or at least carry AIDS, we would want to test whole 
blood in our animal. This is after we have an experimental animal 
to introduce it into. 

Then we would want to fractionate blood to see whether or not 
the active AIDS factor was associated with plasma, with red cells, 
with white cells, with some subset of any of those, whether it was a 
protein, whether it was in fact susceptible to cleaning up, if you 
will, whether it was liable to heat treatment, to various enzymes, 
to pH changes or treatment with urea, all of which would have rel- 
evance in terms of treatment of persons with AIDS, or who must 
have AIDS-free blood products, as well as in developing a vaccine. 

So the point is that merely to discover an animal which is sus- 
ceptible amongst the primates, to conduct our research on, could 
readily and easily cost $200 million or more, might even end up 
costing a great deal more because of the limited number of ways 



154 

we can set about doing such trials. Only then do we begin the kind 
of research that I have described. 

I want to point out a couple of things that I think are important 
in connection with all of this. 

One of them is that I am delighted that as many people have 
spoken as have here today about the costs that are associated with 
doing this work. 

I would like to point out, however, that in the circle of people 
that I have approached and talked to about this, including people 
from the various branches of the Federal agencies dealing with 
AIDS, and with people at universities around the country, they are 
frankly afraid to come and testify at hearings like this because of 
fear. In the case of the governmental workers, repeatedly they 
have told me that they cannot say the things that I am saying, 
much as they concur in them, because they are under an effective 
gag order by the administration in terms of any public statement 
or private statement that differs from the administration's policy 
that budgets in these areas are not to be increased. 

The same holds for many researchers. They, too, are dependent 
upon Federal grants from the NIH or other institutions in the Gov- 
ernment, and are extremely reluctant and fearful of the conse- 
quences and reprisals that will happen if they publicly state the 
things I am telling you. I am not alone in my point of view that I 
am presenting here. And I wish those people could and would come 
forth. But I can see why they do not. 

All of this, these realities of the need for a master plan and the 
costs which I think can hardly be expected to be less than half a 
billion dollars over the next couple of years, not the few millions 
that we have been talking about, but upward of half a billion dol- 
lars, can only be evaluated by taking steps to get a proper assess- 
ment outside the government itself. 

Because of its commitment to defense and not to social service 
projects, I think the administration disqualifies itself instantly. We 
have had repeated testimony today that confirms my view. Why is 
there not even a master plan? Because if there were, everyone 
could see the gross funding deficiency. 

What can be done? 

The National Academy of Science was created, I believe by Presi- 
dent Lincoln a century ago, roughly, to do just this kind of work, 
which is to advise the Government on matters of science. The Insti- 
tute for Medicine at the Academy, or some private group, such as 
the American Public Health Association, should I think be asked to 
do a crash review of all of these issues, and to make recommenda- 
tions of a comprehensive, depoliticized plan of action, and assign a 
properly prepared budget recommendation to accompany the plan. 

It is my belief that unless these steps are taken, hundreds of 
thousands of Americans and people around the world will be killed 
needlessly and inexcusably by AIDS. It has been reported by others 
before me that the cost of medical treatment is about $100,000 per 
person. Since AIDS has been around nearly 3 years now, if we look 
forward another 3 years, we can expect something of the order of 
at least 50,000 people to have AIDS, at $100,000 apiece. Coldheart- 
ed as looking at mere dollars and treatment and hospitalization 



155 



It seems to me that a half billion dollars for research-iust 10 
percent of those hospital costs is a very economical amount of 
money for us to be looking at in the Congress to deal with thi 
AIDS crisis by comparison. 

wh^i W^:/' a scientist who has observed what has happened and 
Tn^ f^f 'if^^'/T ^'' f«"^^^fs are suffering from a lack of funds 
and the kind of master battle plan that is needed, I begin to 
wonder with a certain cynicism if perhaps the only route by which 
we are realistically going to get the needed Federal leadership i^ 
when the Armed Forces begin to turn up cases of AIDS 

And that disaster is happening, though it is not a matter of 
public information yet. Indeed, it is rather shocking to me that the 
public and probably all of you in Congress don't know but there 
are now at least a dozen cases of AIDS in the U.S. Armed Forces 
t^m^tT 'PZ\r;^^'' budgets seem to be without limit,Te may S 
timately find the moneys to do the things we should already be 
doing. We cannot wait. dneduy ue 

Thank you. 

Mr. Weiss. Thank you very much. 

[The prepared statement of Dr. Voeller follows:] 



156 



AIDS RESEARCH AND FUNDING 



by Bruce Voeller, PhD 

♦President, The Mariposa Education 
and Research Foundation 



In testirrony before Congress in the past month. Assistant Secretary for 
Health, Edward Brandt, stataithat AIDS is "our number one priority," a public 
policy H.H.S. Secretary Heckler echoed to the press. H.H.S. action does not 
jibe with its proclaimed policy , however. 

Despite three years of intense interest in the disease, H.H.S. has not 
convened a single national meeting of research scientists and physicians frctn 
the private sector and government to collaborate in developing a cotprehensive 
master plan for discovering the caijse of AIDS and of developing techniques for 
prevening and treating AIDS. 

Nor has H.H.S., or its ccnponent agencies, even yet named standing or ad hoc 
panels of outside authorities to advise and counsel the Department on AIDS, a 
procedure they consider essential in their Department's review of applications 
for scientific research grants given out by the Department. In fact, hastily 
convened ad hoc meetings have been called only on such limited issues as AIDS 
and blood, and AIDS in monkeys (simian AIDS) . In addition, the scientific 
ccmmunity interested in AIDS has received extremely little information fran 
H.H.S. to assist in research or education. As an invited panel member and 
scientist at two of the interagency meetings sponsored by the CDC, NIH and FDA 

(AIDS and Blood) , I have receive no follow-up reports, no research documents — 
in fact no information viiatsoever following the meetings. Indeed, I have had 
to purchase a subscription of the CDC's Morbidity and Mortality Weekly Report 

(MMWR) for myself. Nor have I received a single issue of the AIDS update 
bulleting announced publicly by Secretary Heckler. Even highly publicised 

(through press conferences) announceirent of "breakthroughs" on T-cell viruses 
found in AIDS patients (at NIH) and on trials with Interleucin 2 (NIH and FDA) 
were known to me and fellow scientists through personal contacts and national 
media, rather than scholarly cotnnunication fran the agencies releasing the 
publicity. 

*for identification purpose only 



157 



The need for the federal government to develop a ccxrprehensive master plan 
and to convene a major council of advisors to review and coment upon the plan 
is inperative. The master plan is needed in order: 

1) to assure that all conceivable research concepts and directions are 
envisioned and enumerated nCTv, not merely a list hastily ccnpiled, or 
ones ccnposed mainly of fashionable research areas currently popular in 
select scientific circles, 

2) to assure prioritization of the diverse research projects, in order to 
see that our best leads are pursued now and with vigor , and also to 
assure that long-term projects which nay take several years to corplete 
are not neglected. We dare not risk playing out fashionable leads, seduc- 
tive because of their attendant publicity and celebrity for the researchers 
carrying them out, as well as their supporting institutions, only to 
discover two or five years fron now that the leads were dead ends... only 
than to realize we should have begun the methodical, long-term research 
vdrLch was actually needed. We can always terminate long term projects 

if serendi pitous short term work finds the answers we seek; we can never 
regain the the lost time and lost lives if we are forced to begin the 
traditional, plodding projects at the end of a period of unsuccessful 
attarpts to find quick results, 

3) to assure that each of the many projects which should be listed be period- 
ically and systematically scrutinized anew, as fresh infomation and 
hypotheses emeige which might shift our perception of the relative signif- 
icance. . .either upward or downward, 

4) to assure close examination of the government's AIDS master strategy using 
the same creative and critical peer review which is a standard procedure 
at first-rank scientific journals and research funding institutions, 
including all branches of the H.H.S. We cannot afford to have good 
hypotheses tested through protocols with forseeable limitations or flaws 
which iright have been avoided or circumvented, 

5) to coordinate privately funded research with that undertaken by the 
federal government, or financed by it; we must avoid wasteful, unwitting 
duplication of efforts and the consequent wasting of resources of mney 
and time. 



26-097 0-83 11 



158 



6) tx3 coordinate studies at other governmental levels, including recent 
coimitments made by the City of San Francisco, the state of New York, 
and pending in the state of California, 

7) to develop a budget for AIDS research authentical ly tailored to meet 
the financial requiranents generated by a corprehensive master plan, 
rather than invented to fall within the Mministration ' s policy of 
frozen social service funding. 

In the absence of the fedbral leadership so badly needed in the form of 
such a master plan and its correlated budges, we have seen more than two years 
of fragmented and ill coordinated research conducted on AIDS. The consequence 
is that a cure or preventive procedijre for AIDS evades us and the cause of AIDS 
remains conpletely unknown to us. 

Lacking a master plan acccmpanied by a realistic cost analysis, the 
Administration continues to resists budgetary increases for AIDS. Bihas 
repeatedly danurred to Congressional suggestions of additional funding for medical 
research on AIDS. Fortunately, Congress has taken steps to add about $12,000,000 
to the AIDS budget. The fact is, however, funds vastly greater than any included 
in proposals so far heard fron the government are manifestly needed if one even 
considers a few of the many projects v*iich woiild be essential in a master plan. 

For example, in order even to begin the long process of systematically 
identifying the transmissible agent believed to cause AIDS, we first must find 
and experimental animal vMch is susceptible to AIDS. We need to be able to 
introduce a suspected causal fluid or tissue fron soneone with AIDS into the 
experimental animal to see if it does indeed cause AIDS inttie animal... a part 
of the celebrated "Koch's Postulates" taught every beginning student of biology 
or medicine. Only in this way can we be sure we have identified the correct 
causal agent, even if we have used sophisticated new techniques to bypass much 
traditional procediore for discovering a causal agent. We must do this even if 
we have, for instance, the strongest suspicion that a particular virus rray be 
the cause of AIDS. 

Once a suitable experimental animal is located, it will be possible 
to test suspected agents. A lucky breakthrough might occur this way. More 



159 



likely to be the case, and more laboriously, if no such quick breakthrough 
occurs, test animals can be used to see if fluids and tissues frcm those with 
AIDS induce the disease in the animals. In this fashion we can see whether 
blood, saren, Kaposi tumour tissue, etc., carry AIDS, and then begin to analyze 
vdiat part of sorien, for exanple, carries the causal agent. Or if blood is 
found to be a najor carrier of the infectious agent, we can see if it is in 
(or associated with) the plasT\a,or the vdiite cells, or the red cells. Is 
it a small molecule \*iich will diffuse through membranes? is it a protein? 
a virus-size particle? is it heat labile? susceptible to treatment with 
urea or to pH changes, or to enzymatic ijiactivation? Each question can be 
answered by testing the purified or treated blood product in an experimental 
population of animals. 

Testing of standard laboratory animals such as hamsters, mice, rabbits, 
for their AIDS susceptibility, has failed so far. Therefore we must test as 
many different primate species as possible, because of their far greater 
medical and physiological similarity to human beings. There is no way, 
however, to predict vfcich speci=s of primate will be susceptible, or even if any 
will be. Ftirthermore, we must test each for as long as two years inasmuch as 
in humans, AIDS incubates close to that duration on the average before it 
manifests itself. If the period in primates proves as long as in humans, experi- 
mental primate research will be both very slow and very costly. We must start now . 

According to several different sources at CDC and at American primate 
centers, rhesus monkeys and chirrps, for exanple cost about $100 per day to 
house and to care for in research such as we will need for AIDS studies. To 
intravenously expose twenty- five animals in each of six species of primates, 
with blood from AIDS patients, and to house them for two years, cones to 

$10,950,000 [25 X 6 X 2 X 365 X $100] 

To test just five other body fluids and tissues besides blood, e.g., saliva, 
semen, tumour tissue and fecal material and iirine, would be six times more: 
$65,700,000 [$10,950,000 X 6] 

Since we are imclear vAiat route of introduction of the test materials into the 
animal would work, merely testing three routes ... intravenous , intramuscular and 
intraperitoneal injection. . .would cause the cost to soar another threefold to 
$197,000,000 



160 



This staggering figure is iterely a liniita l array of tests designed cnly to 
discover a susceptible species of animal... so the real research can begin. 
[Note that AIDS cCTitamination of animal housing facilities in these studies 
may well render them unsuitable for future use.] 

The fact is that the cost of this single project is nearly twenty times 
the entire budget the Administration has until recently been proposing for 
all AIDS research. 

The cost of experinental testing of inter leucin 2, to consider another 
exanple, to determine if it is a useful treatment drug for AIDS, is reportedly 
$125,000 per patient. The NIH is, I understand, testing only four patients. 
A full scale test might be of the order of fifty patients, if their is sufficient 
purified, isolated inter leucin 2 to do the studies. At the stated price, the 
cost of such a study will be about $6,000,000, inasmuch as we cannot justify 
waiting many additional months in the hopes that 'synthetic' recanbiant process 
inter leucin 2 will be available presently at a cheaper cost per patient. 

Callous as raw econonics can seen, solving the AIDS m^'stery is plainly 
cost-effective ccrpared with the price of hospital care alone, which now 
approaches $100,000 per case. The number of Icnown AIDS cases nearly doubles 
every six months. AIDS has befen around at least three years; projecting 
forward a similar periods of three years, to 1986, we can expect at least 50,000 
AIDS cases. By the end of that period, the national AIDS treatment bill will be 
over $5,000,000,000 -- five billion dollars. 

In talking with numerous research scientists, both within the government 
and in the private sector, I find they aree with my analysis presented here. . . 
the desparate need for a federal master plan and for the level of financial 
resources I have given a small indication of here. Sadly, most of my colleagues 
are unwilling to cans forward to state their support and concurrence publicly. 
Those in government quite reasonably fear quick termination of their government 
careers if they state their considered scientific beliefs in the face of 
explicit govemitent gag orders. University researchers equally clearly tell 
ne that they fear governmental reprisal if they appear before these hearings 
or speak their minds. These wanen and men are dependent upon government 
research grants in order out their scientific research. . .the sort of work that 
has won Anerica so many Nobel Prises and made us preeminent in science and tech- 
nology. 



161 



All these realities lead me to the conclussion that a more iirpartial 
authority than the current Administration is needed to create a iraster plan 
for AIDS research and to attach realistic costs to the plan. We may in fact 
need an AIDS counterpart, crash-program similar to the Manhattan Project of 
the 1940's. 

Ttie National Acadany of Science was created by President Lincoln a 
century ago to do just this kind of work — advise the government on matters 
of science. The Nationl Acadany , the Institute of Medicine or the American 
Public Health Association should be asked to review the issues and recontiend 
a ccnprehensive, de-politicized plan of action and assign a properly prepared 
budget recatmendation for it. 

It is my belief that unless such steps are taken hundreds of thousands of 
Americans and people around the world will be killed needlessly and inexcuseably 
by AIDS. 



CPMTACT: Dr. Bruce Voeller 

The Mariposa Foundation 
1800 N. Highland Ave. 

Suite 202 
Los Angeles, CA 90028 

(213) 469-3574 



162 

Mr. Weiss. Dr. Bove. 

STATEMENT OF DR. JOSEPH R. BOVE, PROFESSOR OF LABORA- 
TORY MEDICINE, YALE UNIVERSITY SCHOOL OF MEDICINE, 
AND DIRECTOR, BLOOD BANK, YALE-NEW HAVEN HOSPITAL 

Dr. Bove. Thank you. 

Mr. Chairman and members of the committee, I am Joseph R. 
Bove, M.D., professor of laboratory medicine at Yale University 
School of Medicine and director of the blood bank at the Yale-New 
Haven Hospital. 

I have devoted all of my professional life to blood-banking and 
transfusion practice, and, among other things, chair both the Food 
and Drug Administration's Advisory Committee on Blood and 
Blood Products and the American Association of Blood Banks Com- 
mittee on Transfusion-Transmitted Diseases. 

As you might imagine, much of my recent medical effort has 
been devoted to AIDS and its effect on our blood banks and trans- 
fusion recipients. I will be brief with my statement so that your 
questions can focus on whatever may be of specific concern to you. 

First, let me address one area that seems to be of major interest 
to nearly everyone: Has AIDS contaminated our blood supply? As 
of July 11, 1,831 cases of AIDS had been reported to the CDC 
United States only. Of these, 71 percent were in gay males, 17 per- 
cent in IV drug users, 5.4 percent in Haitian entrants, 0.8 percent 
in hemophiliacs, and 5.8 percent, or 107 cases, in individuals with 
no apparent risk factors. 

To the best of my knowledge, this latter group includes fewer 
than 20 individuals who have received blood transfusions and have 
come down with AIDS. In one case, and one case only, has the epi- 
demiologic investigation identified a donor with AIDS. In several 
other cases— still under investigation— there are suspect donors, 
but, as far as I know, in only this one case is a transfusion recipi- 
ent with AIDS linked to a donor with AIDS. Thus, the current total 
of transfusion-related AIDS cases is fewer than 20, with only 1 in 
which an AIDS donor is linked to an AIDS recipient. 

The current AIDS epidemic began in late 1979 or early 1980. In 
1980, the latest year for which there are data, 10,880,079 units of 
blood were collected from volunteer donors and transfused into 
3,271,792 recipients. 

I have no reason to believe that the numbers for 1981, 1982, or 
1983 differ significantly, so we can assume with confidence that 
over 10 million persons have received over 30 million units of vol- 
unteer blood since the AIDS epidemic began. In this vast experi- 
ence the number of transfusion-related cases is under 20. If— and 
there is no evidence yet that this is so— but if all 20 cases under 
investigation by CDC finally turn out to be transfusion-related, the 
incidence will be less than 1 in a million. We do not know that 
AIDS can be spread by transfusion, but that possibility cannot be 
discounted. 

But if AIDS can be spread by transfusion, what we know now 
suggests that the risk is minimal. Much less than the risk of many 
other well-known and accepted risks associated with transfusion, 



163 

with medical practice and with life, itself. Some of these are de- 
tailed in the appended table. 

Over the past 20 years our blood-collecting agencies — the Ameri- 
can Association of Blood Banks, the American Red Cross, and the 
Council of Community Blood Centers— have worked together to de- 
velop the very fine system of voluntary blood banks that serves the 
American public. Over 98 percent of all blood transfusions now 
come from volunteer blood donors. The system is working and 
working well. 

Even if— and it still is a big if— a small number of AIDS cases 
turn out to be transfusion related, I do not believe that this can be 
interpreted to mean that our blood supply is contaminated. Prob- 
ably not, and if not, what has caused the problem facing our blood 
banks? 

First and foremost is the element of hysteria that surrounds the 
disease and anything even remotely related to it. In my view, this 
hysteria is fueled partly by an overreacting press and partly by a 
paucity of public information about the exact nature and number 
of suspected transfusion-related cases. In a setting where the 
amount of information is limited, rumor and anxiety run rampant. 
This anxiety has produced a whole host of unfortunate conse- 
quences. In some areas — certainly not in all, and probably only in a 
few — significant blood shortages are being seen. We cannot be sure 
these are AIDS related, but there is a suspicion that they are. Po- 
tential recipients and their families are beginning to fear transfu- 
sion and, in some instances, are resisting appropriate medical 
treatment because of these fears. 

There has been pressure on blood banks to allow patients to 
select their own donors rather than relying on the community re- 
sources. Such requests have the potential to undermine a fine vol- 
unteer system to the point where it might no longer be able to 
supply the blood needs of most patients who require transfusion. 
The collecting agencies have recognized this and taken a strong po- 
sition against such directed donations. 

Our blood banks are mindful of the heavy responsibility they 
shoulder for a safe blood supply. To this end, they have quickly and 
willingly implemented the FDA's suggestion to provide all poten- 
tial blood donors detailed information about groups at high risk of 
AIDS and ask individuals in any of these groups to refrain volun- 
tarily from donation. If there had been even a small risk of trans- 
fusion-transmitted AIDS in the past, these measures, in place since 
late March, should lower it even further. 

I am in a difficult and delicate position. We are dealing with a 
highly fatal disease of unknown cause which is spread in ways we 
do not understand. Much about the disease suggests that it is an 
infectious illness caused by an unidentified agent. 

There is no test for AIDS and no way to know who, if anyone, is 
a carrier. In this forest of unknowns, a few people who have had 
transfusions have also come down with AIDS. This may be coinci- 
dence, but it seems possible that in an occasional case the two 
events are related. We really do not know. 

Our needs now are to be calm and realistic in appraising the 
medical situation; to take whatever new steps are needed when, 
and only when, they can be justified on medical, scientific, and epi- 



164 

demiologic grounds; to continue to support and nurture the volun- 
teer blood bank system and to reassure — as best we can — those who 
need transfusion. 

We look to CDC for ongoing up-to-date information on which we 
can base future decisions about the Nation's blood supply; to NIH 
for research leadership and support; to FDA for whatever regula- 
tory authority may be needed; and to the Congress, ladies and gen- 
tlemen, for financial and emotional support, financial in the sense 
that the ultimate solution to the AIDS problem will require re- 
search and medical-care dollars, and emotion — if that is the right 
word — so that the public can look to the Hill and see clearcut, un- 
ambiguous support for America's volunteer blood bank system. 

I thank you for this opportunity to appear before your committee 
and am pleased to answer any questions you may have. 

[The table entitled "Societal and Medical Risks," follows:] 



165 



SOCIETAL AND MEDICAL RISKS 



Transfusion Related Risks 

Transfusion transmitted AIDS 
Transfusion transmitted hepatitis 
Transfusion transmitted malaria 
Death from the wrong unit of blood 



1:1,000,000 (perhaps) 
5-7% of all recipients 
1:1,000,000 
1:500,000 



Medically Related Death Rates 

Appendectomy 
Tonsillectomy 
Cholecystectomy 
Hernia Repair 
Dilatation and Curettage 



1 



5,000 

10,000 

625 

5,000 

580 



General Risks (Death/Person/Year)' 

Automobile racing 

Professional boxing 

Motorcycling 

Struck by automobile 

Earthquake (California) 

Floods 



10,000 

14,300 

50 

16,600 

588,000 

455,000 



1. Hospital Mortality. PAS Hospitals, United States 1974-75, 

2. Dinman BD. JAMA 1980;244:1226-1228. 



166 

Mr. Weiss. Thank you very much, Dr. Bove. I want to thank all 
of you on this panel. It was extremely important and informative 
testimony. 

We are now going to break for about a half an hour. 

The cafeteria is still open and will remain open until 2:30; so it 
will allow for some replenishment. We will then resume our activi- 
ties at 2:45 p.m. 

Hopefully, you can all return for questions at that time, and we 
will complete the afternoon's activities with the last remaining 
panel. 

Thank you. 

The committee stands in recess until 2:45 p.m. 

[Whereupon, at 2:10 p.m., the subcommittee recessed, to recon- 
vene at 2:45 p.m. the same day.] 

AFTERNOON SESSION 

Mr. Weiss. The subcommittee will come to order, and if all of our 
witnesses on this panel will resume their place at the witness 
table, we will proceed. 

First, let me apologize for keeping you longer by breaking, but I 
was afraid if we did not, and the questions ran over, there would be 
no occasion for lunch, because the cafeteria closes at 2:30. 

I do appreciate your cooperation and your returning. 

Dr. Bove, let me address a question to you, if I may. 

What steps, in the light of your testimony, do you feel need to be 
taken to allay public concern about the Nation's blood supply? 

Dr. Bove. Information, sir; information. I think we need an on- 
going and open line of information from the CDC, which is current- 
ly the locus from which the case reporting stems to the public. I 
think those of us who are in the blood-collecting industry, who 
have responsibility for the Nation's blood-collecting systems, need 
to know exactly how many suspected cases there are, where they 
are, and at what stage the investigation is. 

Do we have suspect donors? I think that information ought to be 
available not only to us in the blood-collecting group, but to the 
public. This is really public health information, and I think the 
people of this country need to know as quickly as possible what our 
CDC knows about the risks. 

Mr. Weiss. Why do you believe that information has not been 
forthcoming? 

Dr. Bove. I can't answer that. Congressman. I think you have to 
ask others, but I know that there is a feeling on my part, and I 
suspect on the part of others, that the kind of openness about the 
information we think we need has not been available from CDC. 

Mr. Weiss. One of you, though I don't know who, testified that 
the Morbidity and Mortality Weekly Report was changed from a 
free distribution to a paid-for distribution, and I gather from the 
testimony that this was done to comply with budget restraints. 

It is your judgment that the same problems may be present in 
getting all kinds of information from CDC? 

Dr. Bove. I really am not competent to answer that question. 
You better ask the CDC people. 

Mr. Weiss. Well 



167 

Dr. BovE. The Morbidity and Mortality Weekly Report is still 
out, still published every week, and there is an opportunity for 
CDC to write and publish in that information about suspected 
cases, just as they talk about measles, mumps, and chicken pox. 
They could certainly tell us about the suspected transfusion cases. 

Mr. Weiss. When Mr. Brownstein testified earlier, the impression 
I got from his testimony was that he felt that organizationally, the 
National Hemophilia Foundation was, in fact, being reached out to 
by the CDC. 

I guess what you are saying is that whatever information they 
give NHF may be in the very narrow area of their concern, but as 
far as broader information is concerned, to allow you to do your 
work, that information is not available? 

Dr. BovE. I feel that is correct, sir. 

I learned this morning the CDC is supplying the National Hemo- 
philia Society on an ongoing basis about a number of cases of he- 
mophilia and details about them that are suspected and related to 
transfusion of blood products, but the three major blood-collecting 
organizations have not received that information. 

Now that I have learned that it is available, I will see if I can get 
it; but why did I have to learn it here this morning in this way? 

Mr. Weiss. All of you have referred in one way or another to 
what seems to be a lack of a comprehensive approach to dealing 
with this problem. 

Would any of you care to offer some suggestions as to what you 
think ought to be done; how can we get a better coordinated ap- 
proach to deal with this problem? 

Dr. Conant? 

Dr. Conant. Yes, sir, and I think there are a number of different 
ways. It would seem a problem of this magnitude involving as 
many different aspects of our society as it does, and it will continue 
to involve more aspects of society. 

We learned last week that there is now an indication that health 
care workers have acquired the immune deficiency syndrome from 
dealing with patients. 

Questions will be raised about the safety of doing cardiopulmon- 
ary resuscitation on people who may be suffering from AIDS, and 
so there are going to be a variety of different issues arising in the 
immediate future that need to be addressed. 

We should have contingency plans how we will educate the 
public and deal with those problems as each arises in turn. 

I would think that a blue-ribbon overseer committee, answerable 
to the executive branch of Government, perhaps HHS, which could 
look at the various issues that will arise because of this epidemic, 
and assay what is available in the community to respond and come 
up with plans so the Government could respond quickly, could be 
appropriate. 

We have watched the spectre of a 2y2-year wait to get funding 
for research. Some of the issues that could arise regarding this 
problem, we cannot wait IV^ years, and I would see this overseer 
committee looking at not only informational areas — the public 
need areas — but also the research areas as well. 

We heard the other day that a young man in the military had 
been summarily discharged without medical benefits because he 



168 

had developed AIDS. It was suggested that he acquired the disease 
through his own misconduct. I don't need to remind you gentlemen 
that we have Veterans Administration hospitals full of individuals 
who are there because they smoked for many, many years. They 
acquired chronic lung disease, and alcoholism was mentioned earli- 
er. 

If a young man is in a motorcycle accident while on active duty 
and drinking, he is cared for by the military. This man is being de- 
prived medical benefits because he was summarily discharged with 
the argument being he got this through his own misconduct. 

In all probability his attorney will be able to get that overthrown 
in 2 or 3 years. He needs medical benefits now. He will be dead in 
2 or 3 years. There are a whole variety of issues exactly like this, 
where some overseer committee responding to this emergency 
could be extremely useful. 

Dr. VoELLER. I think it is essential there either be standing or ad 
hoc advisory committees from outside the Government to CDC, 
FDA, and NIH on AIDS in general, just as there were to some 
extent with Federal panels which met two different times concern- 
ing AIDS and blood, a year ago now and back on January 4. Two of 
us here served on those panels. 

There is a need to have panels of outside people who can help 
focus and hone plans and bring in new thoughts and ideas to re- 
search programing. I repeat that I think that the most fundamen- 
tal thing of all goes beyond that; it is the need to have a politically 
independent voice, from people who are competent scientists, for 
an overall master plan that probably can only be developed by 
some such agency as the National Academy of Science or the 
American Public Health Associations, as I mentioned earlier. 

Only through that, then, can we turn to a properly conceived 
budget, not plans drawn by political necessities or points of view of 
the administration on the relative importance of the defense 
budget versus health and human services budgets. 
Mr. Weiss. Dr. Siegal? 

Dr. Siegal. I would like to comment on a need for redundancy 
and investigation in this and other diseases. We should not forget 
the importance of serendipitous observations in what should be ob- 
vious to anybody who knows anything about the real process of sci- 
ence. 

I don't think that a close finger on how research is done by a 
steering committee and who does it, and in what type framework, 
is necessarily an approach to be handed down. 

Mr. Weiss. You are not saying that we ought not to make sure 
that the effort is sufficiently well organized, so that we know that 
each area of research is, in fact, being undertaken, or are you? 

Dr. Siegal. No, no. I think that it is important to have a general 
plan of attack. It is clear that we ought to know that the areas of 
importance are being covered and questions that need to be ad- 
dressed are being addressed, but to narrowly take that to mean 
that only one individual laboratory should pursue a particular per- 
spective, I think, would be a mistake. 
Dr. Voeller. I agree. 

Dr. Krim. I would enlarge, approve strongly what Dr. Siegal just 
said. In research, a certain amount of duplication is good and nee- 



169 

essary, because no two people approach the same problem exactly 
the same way, and confirmation of results is always necessary. 

One has to come to the same results two and three times before 
they become completely reliable, and, it is better if confirmation is 
obtained done by different people. 

In my statement, I emphasized that Government should be in- 
volved in the overall planning, but not go into the specifics of the 
research. The latter should be left to the investigators themselves; 
the Government should make sure that all basic areas are covered 
by a sufficient number of laboratories, and that certain facilities 
and resources are made available to them. There is a need for a 
central repository for clinical specimens, for example, because 
many investigators don't have access to patients. Investigators 
should be able to write to somebody and say, I need this type of 
blood sample, or cell, or virus probe, and the Government should 
help make these available. But investigators must be able to work 
independently and freely, and not be asked to verify a hypothesis 
formulated by others. 

Mr. Weiss. All of you are saying basically the same thing. Thank 
you very much. 

Mr. Walker. Dr. Bove, I would like to get a couple of things for 
the public record here. 

Is it safe to have a blood transfusion in this country today? 

Dr. Bove. In terms of AIDS? 

Mr. Walker. Yes. 

Dr. Bove. As far as I know, I think it is. That is my professional 
opinion right now. 

Mr. Walker. Is it safe to give blood? 

Dr. Bove. Absolutely; unquestionably. 

Mr. Walker. Well, I think it is important that we establish those 
two things with an expert for the record, and I thank you for your 
statement on that. 

Dr. Conant, you made three basic points earlier, and I thought 
that your testimony was very good. There was one thing that puz- 
zled me, based upon my own reading on this, as to how it relates, 
and that is — not from the standpoint of what you said, but its ap- 
plication to AIDS — and that is that you said that you don't think 
that we in any way can expect in the context of dealing with this 
disease, that we can expect anyone to cease being human in terms 
of expressing their own sexuality, and that is absolutely a fact. I 
don't disagree with that. 

However, it does seem to me that the expression of sexuality in 
our society is most often in monogamous types of relationships. Is 
it not true that we are dealing with something other than monoga- 
mous relationships in most cases and dealing not just in terms of 
dozens of different sexual liaisons, but in the case of many of the 
people who originally contracted this disease, we are dealing with 
hundreds of different sexual liaisons, which is hardly an expression 
of sexuality which we would normally think was healthy in any 
part of our population? 

I wish you would deal with that question. 

Dr. Conant. It gives me an opportunity to stress a point that we 
have all been making this morning, and that is that the research 



170 

in this particular case, the epidemiological research, has not been 
adequate. 

An epidemiological study is only so good as the design of the 
study, the questions you are asking as a scientist, and the time, ap- 
pointed time, at which you do the study. 

As you heard from some of the patients this morning, the CDC 
study, unfortunately, was not well designed. I don't know whose 
fault that was. It may be that we were dealing with a new history, 
but it was not well defined and not yet even been published, even 
though it was done in the fall of 1981, almost 2 years ago. 

That study showed that the people coming down with AIDS at 
that time were highly promiscuous men, and yet I can tell you, as 
a physician who sees about three new AIDS patients a week now, 
that is not what we are seeing today. We are seeing men who are 
physicians, nurses, attorneys, who are in not totally monogamous 
relationships, but essentially such, and we are seeing large num- 
bers of them; in my practice, probably 50 percent of the patients. 

I had a patient last week, a young man 28 years old, and he 
came in and said, "I think this is Kaposi's sarcoma," and I looked 
up and said, "I think you are right. We will take a biopsy and see." 

He started crying, and he said, I jog 25 miles a week, go to the 
gym every week; I only had sex with three people in my entire life. 
How could this happen to me?" 

Now, the point I would like to make here is that if we had done 
an epidemiological study the morning after Pearl Harbor, we 
would assume that Japan won the war. We need to do ongoing epi- 
demiological studies as this disease evolves, look at who is at risk, 
why are certain people getting it? 

We pointed out in San Francisco we have the largest Asian com- 
munity outside of Asia, and yet there have been only four cases in 
Chinese, Japanese, or Filipinos. Their sexual behavior is no differ- 
ent. 

So we need funds to do these ongoing epidemiological studies. 

Mr. Walker. I don't disagree with that. My question came as a 
response, though, to your point that— I gathered from your points 
that the lifestyle issue should not be considered as a part of this, 
and it seems to me that, based upon the evidence we now have 
before us, we cannot totally ignore some of the lifestyle issues. 

Dr. CoNANT. We have to consider every issue that presents itself. 
Early on, the men we were seeing were very promiscuous men, but 
we are not seeing that today. 

Mr. Walker. You made a reference to the health workers that 
have been discovered recently. Do you have any evidence that 
those are people who were in contact with AIDS victims? 

My understanding of that was that the health workers who have 
come down with AIDS were not people who had had contact with 
AIDS victims. 

Do you have different information on that? 

Dr. CoNANT. I can give you the information published in the 
MMWR last week, and I can tell you what we know from our 
health-care workers at the University of California. 

They cited four individuals who had come down with AIDS. At 
least one of the four cases, the man as far as the CDC can tell, had 
no other risk factors. He was not gay, not a hemophiliac, not a Hai- 



171 

tian, nor a drug user. He worked without gloves frequently in 
areas where surgical procedures were done, and he did report a 
needle stick some 18 months before he became ill. It is not known 
that that needle was contaminated with blood from someone who 
had AIDS. 

He developed Pneumocystis and died of that disease. It is only in- 
ferential; the suggestion, of course, is that he was inoculated in 
some way. 

The reason that we think that that is significant is that, as you 
heard this morning, the AIDS epidemic has many parallels to 
hepatitis B. If it is a viral agent, it would appear that it is being 
transmitted in such a way hepatitis D is. Other groups that are at 
risk for acquiring hepatitis B are health-care providers and physi- 
cians, who do procedures without using gloves. 

We would not be at all surprised to see an occasional health-care 
worker who did acquire AIDS by exposure to these patients. 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Weiss. Mr. McCandless? 

Mr. McCandless. I would like to ask the panel, as a whole, this 
question: 

It is my understanding that embarking upon an experimental 
program for finding an ultimate solution is a building-block proc- 
ess. As you begin to develop the necessary basic criteria, more and 
more people can become involved in trying to further different 
paths that have surfaced. Whether it becomes a dead end, or the 
ultimate solution each path is further broadened until finally you 
have a breakthrough. 

Is this essentially how it works, or do we have the wrong impres- 
sion? 

Dr. SiEGAL. It very often works that way, but many of the most 
important breakthroughs that have occurred in biomedical re- 
search have been sheer accidents, and the discovery of penicillin is 
perhaps the best example, but there are lots of others. The discov- 
ery of the hepatitis B was the result of an accidental observation 
by someone who was prepared to go part of the way and be helped 
out by others. 

Dr. VoELLER. It is important to say that, too, in the context we 
are talking about, we all hope something serendipitous will 
happen, that some lucky break will occur. But we can't bank on 
that or be caught 3 years from now with 50,000 or more people 
dead from AIDS, not having taken the logical steps I spoke of earli- 
er. 

I think it is important not to limit ourselves with the hopes that 
some lucky breakthrough will come up, because we may end up 
with dead ends, even though sometimes the lucky break pays off. 

Dr. SiEGAL. They don't happen unless there are enough people 
looking. 

Mr. McCandless. My concern is this "Government" tends to find 
answers through money, in the sense, that if we throw enough 
money at it, we will ultimately find a solution. 

My Science and Technology Committee believes if we spend 
enough money on a certain type of design for a wing, we will come 
up with a solution to the problem. People tell us we can only spend 
so much and do so much research at a time. 



172 

In this particular case, it would appear to me that the number of 
available resources ultimately simulate research but are somewhat 
limited until such time as other projects or activities have worked 
their way out and these technicians and scientists become availa- 
ble. 

Is that correct? 

Dr. Krim. I think in this case — I tried to say this in my state- 
ment — in this case we have an enormous amount of expertise out 
there, in several areas — biology, genetics, immunology, epidemiol- 
ogy — talent available and willing. Some researchers are working al- 
ready on a shoestring; others would like to work on AIDS but have 
no means to do so now. 

The case of the group which formed the AIDS Medical Founda- 
tion is a good example. We wanted to continue our work, and we 
were sinking for lack of financial support for it. 

I really think that in the case of AIDS research, the major obsta- 
cle is lack of money, and only then lack of a certain amount of or- 
ganizational talent that the Government can provide; but money 
could be spent very quickly, and most usefully. 

Also, AIDS is a problem that has a lot of different facets. It is 
not one narrow problem where one can go only one step at a time. 
There is a range of things one can start doing immediately in dif- 
ferent areas, and many avenues of research can usefully be carried 
out in parallel. 

Dr. CoNANT. I share with you your concern that the hysteria 
around this — we will make this go away by throwing enough 
money at it, and we will quickly get the answer, and the whole 
problem will go away — all of us understand that that is not the 
case. If you don't put enough money there to do the necessary re- 
search, we will never get the answers that we need to stop this 
problem. 

At our institution, for example, which has done a great deal of 
research on this problem, our leading cancer virologists had speci- 
mens from patients with AIDS and was beginning to do work on 
animal models to try to see if he could isolate the virus. It was ap- 
propriate; the university became concerned that the centrifuge he 
was using would become contaminated; and so, from November 
1982 until we got funding in May 1983, that tissue sat there fallow 
with nothing being done because we did not have one $30,000 cen- 
trifuge. 

The State of California last month voted $3 million to supple- 
ment the research that we are prepared right now to do, but we 
cannot find funding at the national level; so, while I agree with 
you that you could throw too much money at it, and it could be 
wasteful, a certain amount of money — and I am afraid that is going 
to be a large amount of money — is going to be necessary if we are 
going to find an answer. 

Mr. McCandless. One other point here, if I may, Mr. Chairman. 

Our public health figures in the various categories show in fiscal 
year 1983 we will have spent $14,532,000 in this field. 

If I understand correctly, there has been no central coordination 
or an information bank set up from which information can be dis- 
seminated. If it were, all parties involved could benefit from it in 
their research. 



173 

I think the terminology is, you have not had any kind of scientif- 
ic meeting on this at the national level. Is this correct? 

Dr. VoELLER. Two things — yes, you did — first, there is no master 
plan. 

There are bits of research being done in different laboratories, 
both in the private sector and in the governmental sector at the 
NIH, et cetera, but there is no master plan that has been developed 
and publicly put forward by the Government which people from all 
the different sectors then could relate to in planning and strategiz- 
ing what they wish to do. 

When I say a master plan, I don't mean it will be dictated or 
overseen by the Government to make sure everybody is doing exact- 
ly what is supposed to be done, but rather a listing of the things 
which we ought to be attending to and different quarters ought to 
be conducting those at this point. We need a general battle plan to 
wage a successful war. 

An example of what's missing: a notion to which we have only 
given lip-service — is raising the funds and conducting the experi- 
ments needed to get a primate animal model to use for further re- 
search. 

The answer to the second part of your question is, as an example 
of it. Dr. Bove and I both served on the two blood and AIDS panels 
held by the Government, as invited guests of the three governmen- 
tal agencies, and neither of us has received any followup reports 
whatever. We have not even received the update bulletin that Sec- 
retary Heckler announced would be put out on AIDS, and indeed, I 
had to subscribe on my own to the MMWR published by the CDC, 
as was mentioned. 

We have gotten no information whatsoever, even as members of 
a Federal panel working with the agencies. 

Other people are in equally bad or worse positions because we at 
least have contacts through our meetings, so we can put in a tele- 
phone call and say, what should I know? What has happened? But 
the rest of the people in the field are dependent upon published re- 
sources and repeatedly seeing press conferences held by members 
of Government, or elsewhere, to publicize research. 

Mr. McCandless. You talked about the primate animals, and 
this says a syndrome resembling AIDS in humans has been ob- 
served in groups of rhesus monkeys at two of the seven NIH divi- 
sions of research-resources-funded regional primate research cen- 
ters. One of these is located in Massachusetts, and the other is in 
California. You go on to talk about the comparison of the symp- 
toms, and indicate that it occurs in some cages, but not in others. It 
would appear to me that this would be the animal or subject you 
are looking for if they come up with the same conclusion or possi- 
ble disease without us even getting involved with it. 

Dr. VoELLER. So far as simian AIDS is concerned, there is no 
reason to believe it is the same or identical to that found in human 
beings. There are experiments being conducted by the NIH in col- 
laboration with people in Massachusetts and the University of Cali- 
fornia at Davis on that. There is I repeat, no, foundation for believ- 
ing that it is the same disease. It is, however, a very important and 
striking parallel model which may serve to edify in what we do 
with human beings. 



26-097 0—83 12 



174 

Dr. SiEGAL. I would like to comment on what I believe to be in 
terms of the Federal response. There, in fact, have been several 
meetings held; held at NIH in September of 1981. We had a meet- 
ing at Mount Sinai in July of 1982 that attracted 600 people, and it 
was funded by NIH. 

The people who have been funded already under the first RFA 
met already in May, and plan to meet roughly quarterly, to coordi- 
nate our own efforts; and within the city of New York, David 
Sencer has been holding meetings monthly at which all the investi- 
gators who were working on AIDS were initially a bit standoffish. 
There has now been a lot of coordination between various groups 
willing to provide information to other people on an ongoing basis, 
and we are seeing a good deal of cooperation and interaction be- 
tween people at the level of grass-roots investigators. 

Dr. VoELLER. We do note that out of all of that discussion, there 
is no master plan circulating for comment, review, or collaboration. 
Mr. Weiss. Thank you very much, Mr. McCandless. I have one or 
two questions as a followup. 

The testimony we have just heard from this panel as well as 
from Ms. Apuzzo was outstanding in delineating the areas of 
unmet needs that we ought to be focusing on in order to have a 
comprehensive way of dealing with this situation. 

Dr. Conant, your statistics, your projections are really awe- 
some—I guess is the word that comes out of my mind. Again, you 
said, I think, that by the end of next year, there would be 12,000 
cases, if nothing intervenes, and you said there would be over three 
million by when? 

Dr. Conant. By the time the next President goes out of office, 5 
years from now, and that is assuming that we continue to double 
every 6 months. 

Now, there is a worst-case scenario, of course. The best-case sce- 
nario is we come up with a vaccine and stop this horror. 

There are cities: if you plot the incidents in New York and then 
the incidents in San Francisco, two curves are identical except they 
are about a year apart. Looking at the appearance of the disease in 
New Orleans, Washington, and Denver, they all have the same par- 
allel curves a year or so down the line, because the incubation 
period is about 18 months, so we expect not only to continue to see 
the disease rise in high incidence areas, but we expect to see the 
base widen across the country. 

The numbers I gave are based on the figures, doubling it every 5 
or 6 months for the next year. 

As the base enlarges, then the rate of doubling will increase, and 
one could come up with a figure that it soon will not be doubling 
every 6 months, but every 5 months, and then every 4 months, and 
then every 3 months, and the figure might reach as high as 20 mil- 
lion cases 5 or 6 years from now. 

Mr. Weiss. Do the rest of you generally agree with those projec- 
tions? Any of you disagree with the projection? 
Dr. Siegal? 

Dr. Siegal. I think that is clearly the worst-case scenario, and it 
is also perhaps fair to argue that infectious diseases tend to use up 
a substratum and eventually saturate a population. 



175 

I don't know whether we can really expect that kind of geomet- 
ric progression going on. People are changing to a certain degree 
the way they behave, and those ways favor the spread of an agent, 
and I think we might expect the changes in behavior will continue 
to increase as this disease increases, but it is quite clear that it has 
to increase to a certain extent because there are a lot of cases in 
the pipeline already about which we can clearly do nothing. 

Mr. Weiss. Right, and, finally, Dr. Voeller, and I think certainly 
others of you, talked about numbers of dollars that would be in- 
volved to stop the epidemic. 

Dr. Krim did not mention a specific dollar, but brought out the 
alternative to not spending dollars. 

Are you all in general agreement that, for example, the figures 
that Dr. Voeller used of $197 million, roughly, to find the appropri- 
ate animal on which to do the research is an accurate projection 
and beyond that, I think somebody else had said that we are really 
talking about a total package somewhere in the vicinity of half a 
billion dollars, $500 million. 

Do those numbers seem to be realistic numbers to you as to what 
the unmet needs are at this moment? 

Dr. Krim? 

Dr. Krim. I mentioned in my statement that we should certainly 
think for something in the order of $100 million, and in addition to 
the $100 million we spend already for these patients who are now 
in experimental treatment. That was mj' estimate of a reasonable 
amount; that would make a difference. 

Mr. Weiss. I want to place this difficult matter in context. We 
are going to have the CDC and other HHS officials here tomorrow. 

The subcommittee has found it almost impossible to get past 
budget numbers until very recently. We still have not been able to 
get future budget projections, because the administration takes the 
position that they are prohibited or forbidden by an Executive 
order from sharing them with us, a total misreading, as far as I am 
concerned, of their obligations and our responsibilities. 

In any event, suffice it to say that for this year, the outside 
number is about $25 million, including $12 million that we more or 
less thrust upon CDC, NIH, HHS. We are a long, long way from 
the kind of dollars that you are talking about. 

You want to make a comment. Dr. Krim? 

Dr. Krim. Yes, Mr. Chairman. These figures of $25 million spent in 
1983 puzzle me. I don't see any evidence for them among my 
colleagues. 

I know of a few hundred thousand dollars that have been spent, 
actually given to three major institutions that I know. But even if 
this was done nationwide, it would amount to $25 million, or $30 
million, or $40 million. 

Mr. Weiss. We will try to tie that down tomorrow, when we have 
Department officials before us. 

Dr. Krim. You should really ask how they arrived at these figures, 
because the NIH has a way of calculating amounts spent on one 
health problem that is often very puzzling. 

For example, AIDS involves immunology. The NIH could say 
that all immunology research is AIDS research. 

Mr. Weiss. Dr. Conant? 



176 

Dr. CoNANT. I wanted to second that. In my testimony I referred 
to double bookkeeping, where any type of cancer which may vague- 
ly be associated with Kaposi's sarcoma appears to be figured into 
the NIH budget, and it would be very good for you to question: 
what are these moneys being used for? Was this research that was 
already underway before the AIDS epidemic even began? 

Mr. Weiss. Thank you. 

Mr. Levin? 

Mr. Levin. Mr. Chairman, just let me say— and I am sorry I 
missed the question-and-answer session— but, as I understand it, 
you have been covering the points that I wanted to raise, or I 
hoped would be raised, trying to project or discuss projections into 
the future, and how conjectural they were, and the potential costs 
to try to combat the problem. 

I will, with interest, try to obtain from your staff, Mr. Chairman, 
as well as the people who are working more directly with me, the 
responses, because, as I sat through this morning's testimony, it 
struck me how important is our oversight responsibility. 

We are not here as advocates, and we are not here to try to ap- 
prove a preordained position. We are here to determine the scope 
of the problem and the adequacy of the response to the problem by 
various institutions, including, and because of our oversight respon- 
sibilities, especially governmental institutions, and I hope very 
much that we can proceed in that spirit, and not to do something 
otherwise, and I think that the testimony that I missed, from what 
I can determine, was especially important in trying to help de- 
scribe the potential dimensions and the varying points of view 
about this, and it should be helpful as we proceed with the rest of 
this hearing and then as we proceed to take testimony from CDC 
and NIH. 

Mr. Weiss. All right. Thank you very much. 

I assume that this panel, too, would find it amenable to respond 
to questions which may be submitted later. 

Thank you all very, very much. We appreciate your contribution 
and your patience. 

The last panel consists of representatives from volunteer service 
organizations: Mel Rosen, Harold Daire, and Christopher Collins. 

Let me mention a few things about the organizations that are 
represented. The Gay Men's Health Crisis represented by Mr. 
Rosen and the Dallas AIDS Project represented by Mr. Daire were 
established specifically to provide support for communities victim- 
ized by the epidemic. 

These organizations and others like them across the country 
have mobilized an exemplary effort to battle not only the medical 
problem, but also to cope with the social, psychological and eco- 
nomic problems associated with AIDS. 

Also with us today are representatives from the Lambda Legal 
Defense and Education Fund, which dedicates itself to protecting 
civil rights of gay men and lesbians, including the issues of confi- 
dentiality. We welcome all of you. 

Mr. Mel Rosen, member of the board of directors, and former ex- 
ecutive director. Gay Men's Health Crisis, Mr. Harold Daire, 
founder and director, Oaklawn Counseling Center, Dallas AIDS 



177 

Project, and Mr. Christopher ColHns, cooperating attorney, Lambda 
Legal Defense and Education Fund. 

If you will stand, I will administer the affirmation. 

Do you affirm to tell the truth, the whole truth and nothing but 
the truth? 

Mr. Rosen. I do. 

Mr. Daire. I do. 

Mr. Collins. I do. 

Mr. Weiss. Let the record indicate that each of the witnesses 
have indicated affirmatively. 

I appreciate the fact that you have been here for the bulk of the 
day, but because the House is in session, we may be called away for 
a vote at any time. 

We have your prepared statements, and they will be entered, 
without objection, into the record in their entirety. 

If you summarize your prepared statement and respond to ques- 
tions, as time allows, it may be the most effective way of proceed- 
ing. I think we will start with you, Mr. Rosen, and then proceed to 
Mr. Daire and Mr. Collins. 

STATEMENT OF MEL ROSEN, GAY MEN'S HEALTH CRISIS, NEW 

YORK CITY 

Mr. Rosen. Thank you, Mr. Chairman. 

I will actually skip through my prepared statement and go down 
to the second page and talk to you about the specific services we 
have had to create within our organization because the community 
and basically the existing social service agencies do not meet the 
emergent needs of people with AIDS. 

When a person is told he or she has AIDS it is not like hearing 
that they have cancer, for example. When you have cancer you are 
told what the diagnosis, prognosis and treatments are. When you 
are told that you have AIDS you are hearing that you have a time 
bomb inside of you, that any day you will get an opportunistic in- 
fection and one of these infections would kill you, usually within 3 
years. 

The person goes into a crisis. In many cases the person with 
AIDS does not have a nuclear family for support. We therefore cre- 
ated a crisis intervention unit of trained lay counselors who get to 
the person with AIDS within 12 hours of their initial phone call to 
us. This counselor actively works with the person with AIDS and 
helps them cope during this initial period. We started with 15 
counselors last October; today we have 175. 

Hopefully the person realizes after a while that they may not die 
tomorrow, next month or next year. At this point we introduce 
them to one of our support groups. People learned to cope from 
each other's experiences. In October we started one group. Today 
we have 12 groups not only for people with AIDS but groups for 
husbands, wives, lovers, friends, mothers, fathers, and significant 
others. Although our name starts with the word "gay," our services 
are offered to and used by all affected people and those around 
them. 

We found that there were many people sent home from hospitals 
who were too sick to take care of themselves. We therefore created 



178 

a buddy system or home attendant service made up of people who 
cook, clean, and generally care for the person at home with AIDS 
who is too sick to take care of themselves. In one case a person 
with AIDS was being thrown out of their house so the buddies 
found him a new apartment and moved him in one weekend. We 
started with 7 buddies; we now have 75. 

The disease does not discriminate for or against people who are 
rich or poor. We found that people making $40,000 a year like my 
client were losing everything they had. Even people who were well- 
insured were wiped out after numerous stays in the hospitals. Each 
opportunistic infection could mean a month or more in the hospi- 
tals. 

We set up a financial aid committee that assisted people with 
AIDS to apply for public assistance benefits they were entitled to. 
We also assisted numerous legislators to put pressure on the Social 
Security Administration to create a definition for AIDS so people 
could get disability insurance. Even when the definition was added, 
it was inadequate. Only people with the CDC definition of AIDS 
are eligible today; for example, herpes osters is not included. 

This forces people with prodromal symptoms to continue to work 
when it is possible that working could hasten a case of full-blown 
AIDS. Our financial aid committee is stretched to its limits at this 
point. 

Dr. Irving Selikoff at Beth Israel Hospital asked me to read into 
the record the case of one person who is not considered to be a 
CDC-defined person with AIDS. I won't do that now because of 
time, but I will give this to you to add into the record. 

Mr. Weiss. Without objection. 

[The information follows:] 



a^/^ 



179 



Irving J. Selikoff, M.D. 

.1 \I^U ) 

4. Results . '' G':,.^'^ 

a. Initial medical findings . 

Immunological status of the study group exhibited far greater com- 
plexity than had been anticipated on the basis of previous reports. 

Many of the 100 men had general symptoms that have been reported as 
associated with AIDS manifestation. Fever lasting more than one week 
was acknowledged by 17%, night sweats by 1A%, unexplained weight loss 
greater than ten pounds by 11% and unusual headaches by 17%. On 
physical examination 48% had palpable lymph nodes felt by the exa- 
mining physician to be clinically abnormal. Inguinal nodes were 
palpable in 47% and 34% had palpable nodes at two or more noninguinal 
sites. Anogenital lesions were noted in 37% by the dermatologist. 

Infections were frequent with venereal infections being most common. 
Gastrointestinal symptoms were common, with 31% having diarrhea last- 
ing more than one week, and respiratory symptoms were also prominent, 
with episodes of dyspnea in 27%. 

Each examinee was sent a summary report of findings (Appendix 2); at 
his request, details of findings were also sent to his physician. 

_ — jCase 1 demonstrates the range of symptoms which may be present with- 
^^- out CDC criteria for AIDS being satisfied. 

Case 1 

The patient reported having had many sexually transmit- 
ted diseases. Hepatitis B occurred in 1979 with relap- 
ses in 1979, 1981 and 1982. His health in general had 
been poor with a 20 pound weight loss, night sweats, 
chills, lymphadenopathy , malaise, fatigue, increased 
nasal stuffiness, moderately severe episodes of short- 
ness of breath, arthralgias, absence of semen on ejacu- 
lation, progressive muscular weakness and loss of 
memory. On physical examination, he had generalized 
palpable nodes, abdominal tenderness, hyperactive 
tendon reflexes, muscular weakness, and molluscum 
contagiosum on his neck. All routine laboratory tests 
were normal. His H/S ratio was 0.8. Other immunolo- 
gical tests were normal except that B-cell function was 
decreased (48: normal '^^65) . The IgG level was 1,777 
mg/dl (normal^^ 1,500). His C-reactive protein level 
was 0.1 (normar*^'' 0.9) . He had no response to recall 
antigens for PPD, mumps, dermatophytin. There was a 19 
mm response to Candida. Subsequent to our examination, 
he developed hepatosplenomegaly and received treatment 
for arthralgias with plasmapheresis to remove circulat- 
ing immune complexes. He remains under the care of has 
physician (July 6, 1983). 



180 

Mr. Rosen. Our hotline which I mentioned earlier started receiv- 
ing about 20 calls a week last summer. It now handles over 1,000 
calls a week. Callers range from those in search of a medical doctor 
familiar with AIDS to people calling in a complete panic over what 
they perceive as a symptom. Thirty volunteers and one full-time 
staff member operate this line. 

While misinformation or sensationalistic reporting has created 
the perception that the general public can contract AIDS through 
casual contact, the reality is that people with AIDS can contract 
opportunistic infections through casual contact with the general 
population. People with AIDS sometimes become shut-ins. We have 
tried to combat this by creating recreational groups that get people 
out of their homes and into social and recreational situations. 

People with AIDS have an average age of 35. In addition they 
often are in nontraditional conjugal relationship. These two factors 
create a multitude of legal problems in terms of wills and power of 
attorney. Hospitals in many cases do not recognize what should be 
considered a common law relationship between two people. We 
have attempted to deal with these legal problems by coordinating a 
network of legal services which advise the person with AIDS of 
their legal rights and responsibilities. 

We have networked with the American Red Cross to establish a 
transportation service providing the means for people with AIDS to 
get back and forth from hospital treatments. In addition, the Red 
Cross trains our buddies in modern home attendant care practice. 

The nonresponse by the public health agencies at all levels of 
Government forced us to create and furnish educational and infor- 
mational services. Two newsletters which were really booklets con- 
taining everything we know to date have been distributed across 
the country to anyone wo asks for them at no charge. This includes 
not only people who request them but hospitals, clinics, mental 
health facilities, and public health facilities. 

In addition, we created a health recommendation brochure which 
has been distributed to half a million people. This brochure con- 
tains information ranging from the symptoms of this new disease 
to a recommendation by a number of physicians for people to limit 
their number of multiple sexual contacts. 

We have an AIDS information van which travels to different 
neighborhoods and distributes educational materials. Trained coun- 
selors are available to speak with people who feel the need to talk 
with someone. 

We have traveled across the United States to give technical as- 
sistance to any group who wish to start an AIDS self-help organiza- 
tion. 

We have rented auditoriums and presented seminars to the com- 
munity presenting doctors, social workers, psychologists, psychia- 
trists, legal experts, and insurance experts. At our last open forum 
seminar 2,500 people showed up. No one can understand what 
problems develop when young people in the community are thrust 
into the mind set of elderly people who are adjusted to death as a 
fact of life. 

We present seminars in hospitals to doctors, nurses, and social 
workers. These seminars focus in on the psychosocial effects of 
AIDS. The Health and Hospital Corp. has contracted with us to 



181 

present these seminars to every one of the hospitals within their 
system. We are currently providing seminars to at least one volun- 
tary hospital each week. So many health groups have asked for 
seminars that we had to procure an auditorium and present a 
seminar to all of them at once. 

In the area of research, we have granted $60,000 to research proj- 
ects which would have had to stop for lack of funding, or which 
could not have gotten started because funding is so slow. 

In the past 3 months a new problem has developed: Housing. 
People with AIDS are being discharged from hospitals penniless 
and homeless. The most that can be done through the city at this 
time is placement in an SRO building. These buildings are dirty, 
dangerous, and certainly not a place where a very sick person 
should live. The distorted image that the press has given this dis- 
ease has caused many people with AIDS to be thrown out of their 
homes. Although we would rather not get into the housing busi- 
ness, we are being pushed to buy a house in order to shelter these 
sick people. I don't think this is our job. 

Over the past year we have gone from an organization of 40 vol- 
unteers to 1,000 volunteers. We now have a full-time core staff of 7, 
everyone else volunteering their time. As a not-for-profit agency, 
we, of course, want to provide medical insurance to our staff. How- 
ever, every major carrier we have contacted has turned us down. If 
this is a sign of the future, then we must act swiftly so that people 
in high-risk groups are not discriminated against when applying 
for insurance. 

The Federal Government has not done its share. You must ap- 
propriate massive sums of money for research into this disease. 
You must appropriate money to the States so they can distribute 
moneys to local self-help organizations or set up their own pro- 
grams. If you are not motivated to help disenfranchised groups, let 
me tell you something as a professional social worker. 

Although it is not much talked about, sexuality is not static. 
People have different sexual preferences throughout their lives. 
This is part of the human condition. Talk by people who would 
turn a medical problem into a political one is disgraceful and be- 
longs in the dark ages. For those who would consider legislating 
morality, this has been tried before without success. The human 
condition is continuously in flux. 

Since most researchers and health officials have determined that 
this disease is sexually transmitted, it is probably the long incuba- 
tion period that has kept the disease for the most part confined to 
certain groups. This will change shortly. There is a steaming loco- 
motive roaring down the tracks at the general population. The 
people of this country depends on your God-given wisdom to ascer- 
tain the eventuality of certain events and to protect them. 

I call upon you to not only appropriate the necessary funds but 
to create an office inside the Department of Health and Human 
Services that does two things: one, to establish a national effort 
that coordinates services to affected individuals and a national edu- 
cational effort to the public at large and, two, gives resources and 
technical assistance to States and self-help organizations in loca- 
tions where the disease is spreading or likely to spread. 

[The prepared statement of Mr. Rosen follows:] 



182 

Prepared Statement of Mel Rosen, Gay Men's Health Crisis, New York City 

In January 1982 about 80 people who had lost friends and 
loved ones to a new and mysterious disease gathered at author 
Larry Kramer's apartment in New York City. There they learned 
from Dr. Alvin Friedman-Kien of New York University Medical 
Center that what appeared to be a new disease was spreading 
among a number of divergent populations. Dr. Friedman-Kien 
warned that if the numbers continued to rise in the following 
months as they had in the previous months we would shortly be 
in the middle of a new epidemic. One member of the group which 
was predominantly gay commented that this could turn out to be 
a terrible health crisis for gay men, hence the name Gay Men's 
Health Crisis. The group decided that they would raise funds 
for research into this new disease and organized a fundraiser 
that April which netted $50,000. At this point they applied 
for tax exempt not-for-profit status. The money raised went to 
research and the establishment of an AIDS hotline. 

Two months later I read about this new organization giving 
away its money to research and was so impressed that I sent them 
a letter offering help, explaining that I was Vice President of a 
large social service agency. Within 2A hours, (the mail service 
worked that day) I was having lunch with the President of the 
Board who asked me to put an organization together. While I did 
not say I would do so, I promised to look into the matter. Over 
the next two weeks I spoke with doctors, researchers and patients. 
I did an unscientific needs assessment survey which made me come 



183 



to the shocking conclusion that the automatic safeguards that 
I thought the government had in place to warn and protect people 
from epidemics did not exist in this case. In a conversation 
with the CDC at that time I remember asking for month-by-month 
statistics on cases and mortality. I remember telling the CDC 
that either they were crazy or I was crazy but their numbers 
reflected an epidemic. I remember visiting Dr. Roger Enlow at 
Beth Israel Hospital who introduced me to a dying patient. 
Imagine my horror when that patient turned out to be an acquaint- 
ance of mine. The patient did not die during that bout with 
that opportunistic infection but became my client (I am a social 
worker) whom I followed through a progression of terrible and 
painful infections until his death three weeks ago. This was a 
man who made $40,000 per year but died destitute. By carrying 
him as a client I was able to help build an agency which would 
respond to the special needs of people with AIDS. Most of these 
services would have been automatic for any terminally ill patient. 
In the cases of the AIDS patients those services were not forth- 
coming. Fear of the diseases, fear of death, fear of disenfran- 
chised minorities all added to the lack of services by private 
and government agencies. What we did to compensate is the 
following . 



c 



When a person is told he or she has AIDS it is not like hear- 
ing that they have cancer, for example. When you have cancer you 
are told what the diagnosis, prognosis and treatments are. When 



184 



you are told that you have AIDS you are hearing that you have a time 
bomb inside of you. That any day you will get an opportunistic 
infection and one of these infections would kill you, usually within 
three years. The person goes into a crisis. In many cases the 
person with AIDS does not have a nuclear family for support. We 
therefore created a Crisis Intervention Unit of trained lay coun- 
selors who get to the person with AIDS within 12 hours of their 
initial phone call to us. This counselor actively works with the 
person with AIDS and helps them cope during this initial period. 
We started with fifteen counselors last October; today we have 175. 

Hopefully the person realizes after a while that they may not 
die tomorrow, next month or next year. At this point we introduce 
them to one of our support groups. People learned to cope from 
each other's experiences. In October we started one group. Today 
we have 12 groups not only for people with AIDS but groups for 
husbands, wives, lovers, friends, mothers, fathers and significant 
others. Although our name starts with the word gay, our services 
are offered to and used by all affected people and those around 
them. 



We found that there were many people sent home from hospitals who 
were too sick to take care of themselves. We therefore created a 
Buddy System or Home Attendant Service made up of people who cook, 
clean and generally care for the person at home with AIDS who is 
too sick to take care of themselves. In one case a person with 



185 



AIDS was being thrown out of their house so the buddies found him 
a new apartment and moved him in one weekend. We started with 
7 buddies; we now have 75. 

The disease does not discriminate for or against people who are 
rich or poor. We found that people making forty thousand dollars 
a year like my client were losing everything they had. Even people 
who were well-insured were wiped out after numerous stays in the 
hospitals. Each opportunistic infection could mean a month or more 
in the hospitals. We set up a financial aid committee that assisted 
people with AIDS to apply for public assistance benefits they were 
entitled to . We also assisted numerous legislators to put pressure 
on the Social Security Administration to create a definition for 
AIDS so people could get Disability Insurance. Even when the defin- 
ition was added it was inadequate. Only people with the CDC defin- 
ition of AIDS are eligible today. This forces people with prodromal 
symptoms to continue to work when it is possible that working could 
hasten a case of full blown AIDS. Our Financial Aid Committee is 
stretched to its limits at this point. 



Our Hotline which I mentioned earlier started receiving about 
20 calls a week last summer. It now handles over 1,000 calls a 
week. Callers range from those in search of a medical doctor fam- 
iliar with AIDS to people calling in a complete panic over what they 
perceive as a symptom. Thirty volunteers and one full time staff 
member operate this line. 



186 



While misinformation or sensationalistic reporting has 
created the perception that the general puolic can contract AIDS 
through casual contact, the reality is that people with AIDS can 
contract opportunistic infections through casual contact with the 
general population. People with AIDS sometimes become shut-ins. 
We have tried to combat this by creating recreational groups that 
get people out of their homes and into social and recreational 
situations. 

People with AIDS have an average age of 35. In addition they 
often are in non-traditional conjugal relationship. These two 
factors create a multitude of legal problems in terms of will and 
power of attorney. Hospitals in many cases do not recognize what 
should be considered a common-law relationship between two people. 
We have attempted to deal with these legal problems by coordinating 
a network of legal services which advise the person with AIDS of 
their legal rights and responsiblities . 

We have networked with the American Red Cross to establish a 
transportation service providing the means for people with AIDS 
to get back and forth from hospital treatments. In addition the 
Red Cross trains our buddies in modern home attendant care practice. 

The non-response by the public health agencies at all levels of 
government -»«ree9 us to create and furnish educational and inform- 
ational services. Two newsletters which were really booklets 



187 



containing everything we know to date have been distributed 
across the country to anyone who asks for them at no charge. 
This includes not only people who request them but hospitals, 
clinics, mental health facilities and public health facilities. 
In addition, we created a health recommendation brochure which has 
been distributed to half a million people. This brochure contains 
information ranging from the symptoms of this new disease to a 
recommendation by a number of physicians for people to limit their 
number of multiple sexual contacts. 

We have an AIDS information y?an which travels to different neigh- 
borhoods and distributes educational materials. Trained counselors 
are available to speak with people who feel the need to talk with 
someone . 

We have traveled across the United States to give technical 
assistance to any group who wish to start an AIDS self-help organ- 
zation. 



We have rented auditoriums and presented seminars to the comm- 
unity presenting doctors, social workers, psychologists, psychi- 
atrists, legal experts, and insurance experts. 2,500 people 
showed up at our last open forum seminar. No one can understand 
what problems develop when young people in the community are 
thrust into the mind set of elderly people who are adjusted to death 
as a fact of life. 



188 



We present seminars in hospitals to doctors, nurses and 
social workers. These seminars focus in on the psychosocial 
affects of AIDS. The Health and Hospital Corporation has contracted 
with us to present these seminars to every one of the hospitals 
within their system. We are currently providing seminars to at 
least one voluntary hospital each week. So many health groups have 
asked for seminars that we had to procure an auditorium and present 
a seminar to all of them at once. 

In the area of research we have granted $60,000 to research 
projects which would have had to stop for lack of funding. 

In the past three months a new problem has developed: 
housing. People with AIDS are being discharged from hospitals 
penniless and homeless. The most that can be done through the city 
at this time is placement in a SRO building. These buildings are 
dirty, dangerous and certainly not a place where a very sick person 
should live. The distorted image that the press has given this 
disease has caused many people with AIDS to be thrown out of their 
homes. Although we would rather not get into the housing business 
we are being pushed to buy a house in order to shelter these sick 
people. I don't think this is our job. 

Over the past year we have gone from an organization of 40 
volunteers to 1,000 volunteers. We now have a full time core 
staff of 7, everyone else volunteering their time. As a not-for- 
profit agency we of course want to provide medical insurance to our 



189 



staff. However, every major carrier we have contacted has turned 
us down. If this is a sign of the future then we must act swiftly 
so that people in high risk groups are not discriminated against 
when applying for insurance. 

I sit before you a very changed man from a year ago when I 
called the CDC. I have discovered that medicine, research and the 
so-called safeguards we have in place to warn us about pending dis- 
asters are political and do not work when disenfranchised minorities 
are involved. When toxic shock and Legionaire's disease first 
came on the scene there was an immediate response by government 
and press. Why did hundreds ofpeople have to die before anyone 
moved in this case? Single people pay a very high percentage of 
their salaries to the federal tax structure. Since most of the 
affected individuals affected by AIDS are single they expect something 
back from the government they trust. It is the American way for us 
to respect and care for the individual person who is in trouble in 
our country. I have become disillusioned about this in the past year 
in relation to our government. However, I take heart in the response 
of the community itself. People from all walks of life have come 
forward. The President of our board is a Fortune 500 corporate exec- 
utive who was a Green Beret in Vietnam. Our Crisis Intervention 
Coordinator was a marine in Vietnam. We have policemen, firemen, 
doctors, nurses, social workers, priests, rabbis; people from all 
walks of life volunteer with us. 

The federal government has not done its share. You must appro- 



26-097 0-83 13 



190 



priate massive sums of money for research into this disease. You 
must appropriate money to the States so they can distribute monies 
to local self-help organizations or set up their own programs. 
If you are not motivated to help disenfranchised groups let me tell 
you something as a professional social worker. Although it is not 
much talked about, sexuality is not static. People have different 
sexual preferences throughout their lives. This is part of the human 
condition. Talk by people who would turn a medical problem into a 
political one is disgraceful and belongs in the dark ages. For those 
who would consider legislating morality, this has been tried before 
without success. The human condition is continuously in flux. Since 
most researchers and health officials have determined that this dis- 
ease is sexually transmitted, it is probably the long incubation 
period that has kept the disease for the most part confined to certain 
groups. This will change shortly. There is a steaming locomotive 
roaring down the tracks at the general population. The people of 
this country depends on your God-given wisdom to ascertain the event- 
uality of certain events and to protect them. 



I call upon you to "ot only appropriate the necessary funds 
but to create an office inside the Department of Health and Human 
Services that does two things: 1) to establish a national effort 
that coordinates services to affected individuals and a national 
educational effort to the public at large and 2) gives resources 
and technical assistance to states and self-help organizations in 
locations where the disease is spreading or likely to soread. 

Thank you for the opportunity to speak with you. 



191 



Mr. Weiss. Mr. Daire. 



STATEMENT OF HAROLD P. DAIRE, FOUNDER AND DIRECTOR, 
OAKLAWN COUNSELING CENTER, DALLAS AIDS PROJECT, 
DALLAS, TEX. 

Mr. Daire. I am deeply honored my testimony has been request- 
ed. 

The following presentation represents my attempts at reporting 
conditions, feelings, needs and recommendations of Texans as ob- 
jectively as I am able. 

We have been forced to spread educational, clearing house, and 
patient support services to AIDS patients and their loved ones 
throughout the State. We also sponsor a 24-hour hotline. However, 
the medical problems of AIDS are really what I have come to 
speak about. 

Solving the AIDS problem requires response and coordination of 
resources at all levels of our society. We are dealing with a medical 
unknown which has vast psychological and sociological implica- 
tions. We must shut the moral door and deal with a medical issue 
now, nonjudgmentally. 

In Texas many efforts are being undertaken in attempts to 
combat the AIDS problem. Attempts at defining the problem are 
uncoordinated and by no means systematic. A Federal task force is 
necessary to help local health officials define their roles. Local 
health care delivery systems are straining internal resources in 
dealing with the AIDS registry in Dallas. There is no registry in 
Houston. Attempts at estimating cases in San Antonio were futile 
with numbers ranging from 10 to 34, depending upon whom I con- 
tacted. 

The time to contain the growth of this epidemic is now, not 2 
years from now. It is imperative that communitywide networks be 
established providing surveillance, health care, and followup. In 
dealing with AIDS, a format by which existing agencies could pro- 
vide some form of health services is in place. It has been suggested 
that we apply strategies already practiced for the containment of 
sexually-transmitted disease. This format must address need with- 
out antagonizing confidentiality and without judging lifestyle. To 
effectively implement the program, the resources of existing struc- 
tures such as the Counseling Center must be increased. 

The definition of AIDS must be reexamined. The current Centers 
for Disease Control definition addresses only those people with 
AIDS who have developed malignancies or opportunistic infections. 

Physicians at M.D. Anderson Hospital in Houston, Tex., have ex- 
panded the CDC definition to include the term "AIDS-related com- 
plex." This has enabled the physicians to intervene as early as pos- 
sible in order to affect cure or remission. It enables health officials 
to conduct follow-up on exposed individuals early, allowing staff to 
contact those individuals who are at risk, providing them with in- 
formation necessary to contain the spread of AIDS. AIDS-related 
complex does not necessarily develop into AIDS. Some recover from 
the symptoms spontaneously. 

To support a statement made by Dr. Hirsh recently, in combat- 
ing AIDS, research is of primary importance. However, reason 



192 

must be used in assigning projects which may be harmful. A case 
in point: According to Dr. Peter Mansell of M. D. Anderson, Hous- 
ton, chemotherapy is not the first treatment of choice for Kaposi's 
sarcoma in most patients. Dr. Evan Hirsh of M. D. Anderson, Hous- 
ton, stated, "Chemotherapy is often lethal to KS/AIDS patients 
* * *." Both recommended the use of interferon drugs. 

It has been described as a critical issue of major importance that 
the FDA approve the use of interferon without randomized clinical 
trials. Patients will be killed using the trials. Based on studies in 
San Francisco, New York, Los Angeles, and Houston, interferon 
studies are the same. Interferon is relatively nontoxic. It is impor- 
tant to advocate the patient's right to select among treatment mo- 
dalities and to know what is being dripped into their veins. 

Along the lines of patient support, the overriding issue in Texas 
stems from the destructive effect of AIDS on a person's entire 
social network. People with AIDS often lose jobs, residence, money, 
friends, and family. 

In Texas, as in other major areas of the United States, communi- 
ties have organized groups to meet patient's psychosocial needs and 
provide education. Unlike New York City, San Francisco, and Los 
Angeles, organizations in Dallas and Houston are entirely depend- 
ent upon private contributions to fund support services. The KS 
AIDS Foundation and Committee for Public Health Awareness of 
Houston, the Oak Lawn Counseling Center AIDS Project, the 
Dallas Gay Alliance and the Dallas AIDS Action Project have been 
hampered in their efforts to petition for State and municipal funds 
because time and energy must be devoted to combat groups such as 
Dallas Doctors Against AIDS and Alert Citizens of Texas. Any ef- 
forts to express needs for State AIDS funding have been neutral- 
ized by the negativism of these groups. 

On the municipal level, community organizations have petitioned 
their cities for support. How the cities have responded so far 
amounts to little more than lip service. The city of Dallas passed a 
resolution supporting the need for the release of Federal funds. 
The city of Houston appropriated $78,000 to fund a State-mandated 
AIDS registry. In Houston, the funds have not become available 
nor the registry established. 

On a national level, funds are being released at a trickle, not 
nearly in amounts needed to stem the tide of an epidemic termed 
"the number one health priority of the Public Health Service." 
None of the funds are earmarked for education or patient support. 

Federal funds are needed by community agencies in order to 
enable them to realistically provide support to people with AIDS 
and their respective communities. Major cities with AIDS problems 
such as Houston and Dallas are in need of residences halfway 
house, social services, food transportation, and nursing services. 
Community volunteer groups are becoming financially strained. 
Funds must be made available to support these efforts. 

Evidence of grassroots concern is supported by the fact that na- 
tionally on local levels, independently nearly 40 AIDS support or- 
ganizations have been formed over the past year. These groups 
have coalesced to form a national AIDS support federation, the fed- 
eration of AIDS-related organizations. Why isn't there a coordinat- 
ed response from governmental health agencies? 



193 

After completing the investigation and assimilating the feelings 
of many individuals, I have become convinced that the lack of re- 
sponse from every health agency in this country is intentional. 

Denial of the problem is evidenced by the fact that there is no 
workable definition of AIDS. Denial of the problem's magnitude is 
evidenced by the fact that there are no effective registries operat- 
ing in the State. Lack of concern is evidenced by the fact that there 
is no support of organizations which provide support and followup, 
nor have programs been implemented which could stem the growth 
and spread of the epidemic. The disease, although renamed AIDS, 
still invokes the classical response toward the homosexual commu- 
nity. "We don't care. Furthermore, drop dead." The irony of this 
lack of response by the Federal Government is potentially telling 
all U.S. citizens to drop dead. 

I thank you for this opportunity for presentation. 

Mr. Weiss. Thank you very much. 

[The prepared statement of Mr. Daire follows:] 



194 

Prepared Statement of Harold P. Daire, Dallas, Tex. 

Mr. Chairmem and Members of the Committee: 

My name is Harold Paul Daire. I am a resident of Dallas, Texas. I 
am a licensed mental health counselor in Texas, I am Founder and Executive 
Director of the OeUc Lawn Counseling Center in Dallas, Founder and Coordi- 
nator of the Oak Lawn Counseling Center AIDS Program in Dallas, co-founder 
euid patient support chairman of the Dallas AIDS Action Project. I am a 
member of the Dallas Gay Alliance, an organization which maintains an AIDS 
Task Force for the Dallas Community. I have been actively involved in 
local public health issues since 1980. 

Early in 1980, I watched while a friend wasted away and finaly died 
of a rare cancer and pneumonia. The case was baffling to medical practi- 
tioners. Since then I have experienced the loss of six others. I have 
been affected. I am saddened, I am afraid, I am more sensitive, I am 
concerned, I am involved, I am angry. 

AIDS is a disease which is relatively new to us , bringing with it new 
sets of problems. Medical scientists are puzzled. Health workers are 
misinformed. The general public is panic stricken, reacting with fear, 
paranoia and anger towards high risk group. Those defined at high risk 
for AIDS are rallied in concern, pushing themselves beyond points of 
exhaustion to provide assistance and support to one another. People with 
AIDS are living each day coping with moralistic stigmas attached to a 
medical phenomenon, hoping each new day will uncover clues to solve the 
mystery, yet knowing that without solutions, each new day brings them one 
day closer to almost certain death. 

Solving the AIDS problem requires response and coordination of resources 
at all levels of our society. We are dealing with a medical unknown which 
has vast psychological and sociological implications. We must shut the 
moral door and deal with a medical issue now, non-judgmentally . 

In Texas , many efforts are being undertaken in attempts to combat the 
AIDS problem. Attempts at defining the problem are uncoordinated and by 
no means systematic. A federal task force is necessary to help local health 
officials define their roles. Local health care delivery systems are 
straining internal resources in dealing with the AIDS registry in Dallas. 
There is no registry in Houston. Attempts at estimating cases in San Antonio 
were 'futile with numbers fiihgrng ' from ten to thirty four depiending upon whom 
I contacted. 



195 



The time to contain the growth of this epidemic is now. Not two years 
from now. It is imperative that community-wide networks be established 
providing surveillance, health care and follow-up. In dealing with AIDS, 
a format by which existing agencies could provide some form of health 
services is in place. It has been suggested that we apply strategies 
already practiced for the containment of Sexually Transmitted Diseases 
(S.T.D.s). This format addresses needs without antagonizing confidentiality 
and without judging lifestyle. To effectively implement the program, the 
resources of existing structures must be increased. 

The definition of AIDS must be reexamined. The current Center for 
Disease Control definition addresses only those people with AIDS who have 
developed malignancies or opportunistic infections. Physicians at M. D. 
Anderson Hospital in Houston, Texas have expanded the CDC definition to 
include the term AIDS Related Complex. This has enabled the physicians 
tjo intervene as early as possible in order to affect cure or remission. 
It enables health officials to conduct follow-up on exposed individuals 
early, allowing staff to contact those individuals who are at risk, 
providing them with information necessary to contain the spread of AIDS. 
AIDS Related Complex does not necessarily develop into AIDS. Some recover 
from the symptoms spontaneously. 

In combatting AIDS, research is of primary importance. However, reason 
must be used in assigning projects which may be harmful. A case in point: 
According to Dr. Peter Mansell of M. D. Anderson, Houston, chemotherapy is 
not the first treatment of choice for Kaposi's Sarcoma in most patients. 
Dr. Evan Hirsh of M. D. Anderson, Houston, stated, "chemotherapy is often 
lethal to K.S./AIDS patients. . .". Both recommended the use of Interferon 
drugs. It has been described as a critical issue of major importance that 
the F.D.A. approve the use of Interferon without randomized clinical trials. 
Patients will be killed using the trials. Based on studies in San Francisco, 
New York, Los Angeles and Houston, interferon studies are the same. 
Interferon is relatively non-toxic. It is important to advocate the 
patient's right to select among treatment modalities and to know what is 
being dripped into their veins. 

Along the lines of patient support, the overriding issue in Texas stems 
from the destructive effect of AIDS on a person's entire social network. 
People with AIDS often lose jobs, residences, money, friends and family. 



196 



In Texas, as in other major areas of the U.S., commimities have orgemized 
groups to meet patients s psychosocial needs and provide education. Unlike 
New York City, San Francisco and Los Angeles, organizations in Dallas cind 
Houston are entirely dependent upon private contributions to fvmd support 
services. The K.S./AIDS Foundation and Committee for Public Health Aware- 
ness of Houston, the Oak Lawn Coionseling Center AIDS Project, The Dallas 
Gay Alliance and the Dallas AIDS Action Project have been hampered in their 
efforts to petition for state and municipal funds because time and energy 
must be devoted to combat antagonistic groups such as Dallas Doctors Against 
AIDS and Alert Citizens of Texas. Any efforts to express needs for state 
AIDS funding have been neutralized by the negativism of these groups. 

On the municipal level, community organizations have petitioned their 
cities for support. How the cities have responded so far amounts to little 
more than lip service. The City of Dallas passed a resolution supporting 
the need for the release of Federal funds. The City of Houston appropriated 
$78,000 to fund a state mandated AIDS registry. In Houston, the funds have 
not become available nor the registry established. 

On a national level, funds are being released at a trickle, not 
nearly in amounts needed to stem the tide of em epidemic termed "the 
number one health priority of the Public Health Service." None of the 
funds are earmarked for education or patient support. 

Federal funds are needed by community agencies in order to enable them 
to realistically provide support to people with AIDS and their respective 
communities. Major cities with AIDS problems such as Houston and Dallas 
are in need of residences, halfway houses, social services, food, trans- 
portation and nursing services. Community volunteer groups are becoming 
financially strained. Funds must be made available to support these 
efforts. 

Dallas and Houston media and press have presented balanced, non- 
judgmental coverage. This has assisted our groups in maintaining a minimal 
level of paranoia in the commxinity which is being created by Dallas Doctors 
Against AIDS and Alert Citizens of Texas. 

Evidence of grass roots concern is supported by the fact that across 
the nation at local levels, nearly 40 independent AIDS support organiza- 
tions have been formed over the past year. These groups have coalesced 
to form a national AIDS support federation . . . the Federation of AIDS 
Related Organizations. Why isn't there a coordinated response from 
governmental health agencies? 



197 



After completing the investigation and assimilating the feelings of 
many individuals, I have become convinced that the lack of response from 
every health agency in this country is intentional. 

Denial of the problem is evidenced by the fact that there is no work- 
able definition of AIDS. Denial of the problem's magnitude is evidenced 
by the fact that there are no effective registries operating in the State. 
Lack of concern is evidenced by the fact that there is no support of 
organizations which provide support and follow-up, nor have programs been 
implemented which could stem the growth and spread of the epidemic. The 
disease, although renamed AIDS, still invokes the classical response 
towards the homosexual community. . ."We don't care. . .furthermore. . . 
drop dead." The irony of this lack of response by the Federal Government 
is potentially telling all U.S. citizens to. . ."Drop dead." 



198 



OAK LAWN COUNSELING CENTER 
A-j;.D.S.. Action Project - Dallas 

21i;-528-2l8l 
The AIDS Action Project - Dallas consists or three components 
(1) Community Education; (2) Clearinghouse; (3) Patient 
Support Services. Each component is briefly outlined below 
with an indication of some tasks required to carry out the 
activities. 

I. Community Education 

A. Target group (ff) - The Dallsa and North Texas gay 

community, local health proresaionals, 
and the: medl&. 

B. Objectivea 

1. To inform target groups about: a) the nature and extent 
of the AIDS problem, aspacially in the Dallas area; 

b) the steps recommended/available to prevent, detect, 
and treal; AIDS-ralated conditions; and the types 
of services available in the Dallas area. • 

2. To motivate target groups to: a) take potentially 
appropriate preventive actions; b) seek screening, 
diagnostic, treatment and support services as necessary; 
c) support the. AIDS Action Project through fund giving, 
voluntearing or other assistance 

C. Description - Major elements of the community education 
program include: 

1. Distribution of educational materials 

2. Produce quarterly AIDS Information Forums 

5. Provide video tapes of the AIDS Forums and other AIDS 

information for viewing at the OLCC. 
^. Promote articles, news reports, end public service 

announcements which emphasize accurate, up-to-date, 

"non- judgemental" and balanced information about 

AIDS and AIDS services. 



199 



II. ClearinRfaouse 

A. Target group(s) - the Dallas metroplex and northern Te-xas 

gay community; local health care pro- 
fessionals and facilities. 

B. Objectives 

1. To collect and monitor information about AIDS medical 

cases^ 
2- To answer community inquiras concerning tha AIDS 

problem, available services, and types of assistance 

community members can provide to the AIDS Action ^ 

Project. 

3. To refer individuals- to screening, diagnostic, treatment, 
and support services as appropriate.. 

C. Description - Major clearinghouse activities include: 

1. Establishment of an ongoing system at OLCC for reporting 
and monitoring of AIDS cases 

2. Implementation of an AIDS Information Line to answer 
community inquiries, refer individuals to needed, 
services, collect possible CHse information, and' 
and respond to spaciail requests from the medical 
community. 

III. Patient Support Services 

A. Target group (s) - those diagnosed as having acquired 

immune: deficiencies and/or AIDS 
related conditions; family, friends 
and. loved ones of AIDS patients. 
B.. Objective 

1. To provide a coordinated program of counseling and 
social support services for target group members. 
C. Description - services will be provided through the 
OLCC (but not necessarily be limited to). 
1. Individual and group counseling of AIDS patients, 
family members, friends, and loved ones to assist 
them to "work through" the stages of illness and 
cope with the medical and social - psychological 
implications of AIDS' 
2. Establishment of a "buddy system" for AIDS patients 

Under this system, volunteers would be trained to assess- 
patient needs: during home or hospital visits and 
provide support services. 



200 

DALLAS A.I.D.S. ACTION PROJECT 
(DAAP) 



To Our Friends In The Community, 



The Dallas AIDS Action Project (DAAP) would like to Invite 
you to join us on Sunday, June 19, at 8:00 PM at the Gran Crystal 
Palace in Dallas for a benefit performance by Samantha Samuels. 

Proceeds from this event will be used to fund the activities 
of the DAAP in the Dallas area. These activities include: 

1) Research to find a cure for AIDS 

2) Education to increase public awareness about AIDS 

3) Epidemiology to trace the epidemic aspects of AIDS 

4) Patient support to assist those in need of treatment 

I know that you feel as we do that AIDS is a frightening, 
malicious, life-threatening disease. Since the government is 
responding very slowly in providing sufficient funding for these 
projects, the private sector (you and I and the entire community) 
must act, and we must act immedlaitely ! 

Your contribution is tax deductible and will be greatly ■ 
appreciated. Please contribute. Please help end the nightmare 
of AIDS. Please join us in taking action now against AIDS. 



Sincerely and Urgently, 

Ed Fugate, Fuiyl Raising Director 
Dallas AIDS Action Project 




TICKET PRICE: $10.00 per person 

Make Checks Payable to: DAAP (Dallas AIDS Action Project) 

Pick up tickets at: (1) Crossroads Market on Cedar Springs, or 

(2) Oak Lawn Mail Services, 3S27 Oak Lawn 
Call for more Information: 521-8919 or 522-6900 



DAAP COMMITTE MEMBERS: 



Dr. Jim Wheeler, Mark Harris, Terry Tebedo, 

Al Leviton, Ed Fugate, Ed Frick, Paul Fielding, 

Mike Burnett, Jerry Campbell, Howie Daire, 

and many other concerned friends in the community 



201 



Involvment of the Dallas Gay Alliance in AIDS in Dallas 



Since one of the primary purposes of the Dallas Gay Alliance is 
education, we strive to educate the gay community about AIDS, and 
how it affects them. We have published three brochures, one on 
what is known about AIDS, one on blood donations, and the third 
is on safe sex practices. 

We have printed approximately 15,000 of the first AIDS brochure, 
and know that several other cities in Texas, including Houston asked 
if they could copy it. Funding for printing was from the Club Baths 
and AIDS Action Project. 

The Blood Bank brochure was used only by a couple of blood plasma 
centers, because shortly after meeting with all the blood banks in 
Dallas, the ABBA came out with their own guidelines, and they have 
all decided to use them in some form. The meeting however, with 
all the blood banks was a useful exchange of information, and an 
opportunity for us to show the concern that the gay community has 
for this problem, and that we wanted to cooperate in any way possible. 

Our latest brochure on safe sex practices will have an initial 
printing of 10,000 copies, and will be funded by either/or the 
Dallas County Health Department or Dallas Aids Action Project. 

We also undertook a petition drive, that has gotten over 6,000 
signature of people from throughout North Texas that are concerned 
about AIDS, and requesting that congress appropriate funding for 
research. Copies of these petitions were personally delivered to 
Martin Frost and Steve Bartlett. John Bryant was contacted, and 
said since he would support funding that we did not need to send 
copies of the signatures to him. 

The Dallas Gay Alliance met with Craig Holcomb, City Councilperson, 
and he presented a resolution, that passed unanimously, and called 
for the federal government to fund new research dollars to AIDS. This 
was the first southern city to pass such a resolution. 



Observations: 



The biggest problem in Dallas now is the fear in the gay community 
of what AIDS is, and how they may catch it. Many of us have instantly 
self diagnosed any illness as AIDS, and this fear keeps many from 
being well. 

Dallas needs money for research projects that can be accomplished 
here at Southwestern Medical School. The funding for such projects 
should be made more expediently that has been reported in the past. 

We also need money for support services, for AIDS patients, and those 
that are affected by the loss of a patient. 



Tom Hatfield 



202 

INTRODUCTION BY 
REPRESENTATIVE BILL CEVERHA 



On August 17, 1982, Federal Judge Jerry Buchmeyer, 
declared the Texas Sodomy Law, Section 21.06 of the Texas 
Penal Code, to be unconstitutional. A notice of appeal 
was filed by Attorney General Mark White, on November 1, 
1932. On March 11, 1983, the last day on which a new bill 
could be introduced in the House of Representatives, Attorney 
General Jim Mattox, dropped the State's appeal of the Baker 
V. Wade decision. In dropping the appeal, Mr. Mattox sug- 
gested that the legislature should reintroduce a sodomy law 
if it thought it was in the public's interest. 

The Baker v. Wade case was tried in June of 1981. No 
evidence of the public health threat caused by homosexual 
conduct was introduced at the trial court. The Attorney 
General has made no effort to ask the District Court to re- 
open the evidence to introduce the overwhelming medical evi- 
dence concerning the public health threat caused by homo- 
sexual conduct. 

The diseases being transmitted by homosexuals and being 
caught by homosexuals dxiring their sexual practices threaten 
to destroy the public health of the State of Texas. One of 
the most recent and deadly diseases is Acquired Immunological 
Deficiency Syndrome ("AIDS") . Two recent articles in "Time" 
magazine, March 28, 1983, and "Newsweek" magazine, April 18, 
1983, confirm the deadly consequences of AIDS. Both articles 
also confirm that AIDS first occurred in the homosexual com- 
munity either through their sexual practices, blood donations 
or through close contact with the heterosexual community. 

The citizens of the State of Texas must be protected 
from the spread of AIDS and other sexually- transmitted diseases 
which occur as a result of homosexual conduct. House Bill 2138 
has been introduced for the purpose of preventing and deterring 
homosexual conduct which causes the transmission of disease. 



CSH.B. No. 2138 



203 



A BILL TO BE ENTITLED AN ACT 

relating to defming deviate sexual intercourse, sexual 
intercourse, intimate sexual contact, sexual contact, 
homosexual conduct, pubbc lewdness, medical purposes, 
and defmmg the penalties for homosexual conduct, pub- 
lic lewdness, mcluding the offering, agreeing with or 
soliataiion of such conduct; providing penalties for 
homosexual conduct or the offenng, agreemg with or 
solicitation of homosexual conduct, or intimate homo- 
sexual contact; amending the Penal Code. Sections 21.01, 
21.04. 21.06. 21.07, 21.10. 21.11. and adding thereto a 
new section 21.14, and declanng an emergency. 

BE IT ENACTED BY THE LECrSLATUREOF THE STATE 
OFTE.XAS 

SECTION 1. Section 21.01. Penal Code, is amended to read 
as follows: 

21.01 Definiiions in this chapter: 

(1) "Deviate sexual intercourse" means: (A) any contact be- 
tween jny pjit uf the genitals ot one person and the mouth or 
anus ot" jnoiher person, oi (B) the penetration by one person of 
the genitals or the anus of another person with an object, except 
for medical purposes; (C) any contact belween the mouth of one 
person and the anus of another person; or (D) the penetration by 
one person of (he genitals or the anus of another person with any 
portion of the body (mcluding, by way of example, but not limi- 
tation, a finger, hand or foot), except that any penetration of the 
female sex organ by the male sex organ shall not be included, and 
except for medical purposes. 

l2) "Intimate sexual contact" means the touching by one per- 
son of [he anus, breast, or any pan of the genitals of another per- 
son with the intent or purpose of arousing or gratifying the sexual 
desire of any person. 

(3) 'Sexual contact" means the touching by one person of 
jny pari of the body of another person with the intent or purpose 
of arousing or Bjatifymg the sexual desire of any person. 

(4) "Sexual intercourse" means any penetration of the female 
icx organ by the male sex organ. 

i5) "Medical purposes" means any medically necessary lieal- 
ment by or ai the duection of a physician or other health care 
practitioner ln-ensed to practice medicine in this State. 

SECTION 2. Section 21.04, Penal Code, is amended to read 
as follows 

21.04. Sexual Abuse (a) .\ person commits an offense if. 
without the other person's consent and with intent to arouse or 
gratify the sexual desire of any person, the actor: 

(1) engages m deviate sexual intercourse with the other per- 
son, not hii spouse, whether the other person is of the same or 
opposite sex. (2) compels the other person to engage in sexual 
intercourse, deviate sexual intercourse or intimate sexual contact 
with 3 third person, whether the other person is of the same sex 
as or opposite sex from the third person, ( 3) engages in intimate 
sexual contai:t with the other person, not his spouse, whether the 
other person is of the same or opposite sex. or (4) engages m sex- 
ual contact with the other person, not hjs spouse, whether the 
other person is of the same or opposite sex. 

(b) The conduct referred to in subsection (a) is without the 
other person's consent under one oi more of, but not bmited to, 
the following circumstances. 

( IJ the actor compels the other person to submit or participate 
by force that overcomes such earnest resistance as might be 
reasonably expected under the circumstances; (2) the actor com- 
pels the other person to submil or participate by any threat, 
communicated by actions, words, or deeds, that would prevent 
resistance by a person of ordinary resolution, under the same ot 
simitar circumstances, because of a reasonable fear of harm. (3) 
the other person has not consented and the actor knows the 
other person is unconscious or physically unable to resist; (4) the 
actor knows that as a result of mental disease or defect the other 
person is at the time of the act incapable either of appraising ihc 
nature of the act or of resisting it; (5) the other person has not 
consented and the actor Hnows the other person is unaware that 
the act IS occurrmg; (6) the actor knows thai the other person 
submiis Of participates because of the erroneous belief that he is 
the other person's spouse, or (7) the actor has intentionally im- 
paired the other person's power to appraise or control the other 
persons conduct by admmisienng any substance without the 
other person's knowledge. 

SECTION 3. Section 21.06. Penal Code, is amended 
to read as follows: 

(a) Deviate Sexual Intercourse 

(!) A person commits an offense if he engages in 
deviate sexual intercourse with another individual of the 
same sex. 

(2} An offense under this subsection is a Class A 
misdemeanor unless the actor has previously been con- 
victed under this subsection in which event if is a felony 
of the third degree. 

(b) Intimate Sexual Contact 

(1) A person commits an offense if he engages in 
intimate sexual contact with another individual of the 
same sex. 

(2) An offense under this subsection is a Class B 
misdemeanor unless the actor has previously been con- 
victed under this subsection, in which event it is a Class 
A misdemeanor. 

SECTION 4. Section 21.07, Penal Code, is amended to read 
as follows 

21.07 PubUc Lewdness 

(a) A person commits an offense if he knowingly or recklessly 
engages in any of the following acts in a pubbc place or, if not in 
a pubbc place, he is reckless about whether another person is 
present who will, or may. be offended or alarmed by his act: 

(1) an act of sexual intercourse. (2) an act of deviate sexual 
intercourse. ( 3) an act of intimate sexual contact, (4) an act in- 
volving contact between the person's mouth or genitals and the 
anus or genilals of an arumal or fowl. 

[Emphasis added.] 



(b) A person commits an offense if he knowingly or recklessly 
engages in sexual contact with a pf'ison of thj same sex in a putv 
lic place or, if not in a public place, he is reckless about whether 
another person is present who will, or may, be offended or 
alarmed by his act 

SECTION 5. Section 21.11, Penal Code, is amended to read 
as follows: 

21.11 Indecency with a Child. 

(a) A person commits an offense if, with a child younger 
than 17 years and not his spouse, whether the child is of the 
same or opposite sex, he: 

(1) engages in sexual contact or intimate sexual contact with 
the child; or (2) exposes his anus or any part of his genitals, 
knowing the child is present, with intent to arouse or gratify the 
sexual desire of any person. 

(b) It IS a defense to prosecution under this section that the 
child was at the time of the alleged offense 14 years or older and 
had. prior to the time of the alleged offense, engaged promiscu- 
ously in: 

(1) sexual intercourse; (2) deviate sexual intercourse; (3) in- 
timate sexual contact; (4) sexual contact or; (5) indecent ex- 
posure as defined in subsection (a)(2) of this section. 

(c) It IS an affirmative defense to prosecution under this sec- 
tion that the actor was not more than two years older than the 
victim and of the opposite sex. 

SECTION 6. Chapter 21, Penal Code, as amended, is 
amended by adding thereto Section 21.14 to read as 
follows; 

21.14. Homosexual Conduct - Offenng, Agreemg, or 
Soliciting 

(a) Deviate Sexual Intercourse 

(J) A person commits an offense if he offers, agrees 
with, or solicits another individual of the same sex to en- 
gage in deviate sexual intercourse for the purpose of 
arousing or gratifying the sexual desire of any person. 

(2) An offense under this subsection is a Class B 
misdemeanor unless the actor has previously been con- 
victed under this subsection, in which event it is a Class 
A misdemeanor. 

(b) Intimate Sexual Contact 

(I) A person commits an offense if he offers, agrees 
with, or solicits another individual of the same sex to en- 
gage in intimate sexual contact for the purpose of 
arousing or gratifying the sexual desire of any person. 

(2} An offense under this subsection is a Class C 
misdemeanor unless the actor has previously been con- 
victed under this subsection, in which event it is a Class 
B misdemeanor. 

SECTION 7. The importance of this legislation and 
the crowded condition in both houses create an emer- 
gency and an imperative public necessity that the con- 
stitutional rule requiring bills to be read on three several 
days in each house be suspended, and this rule is hereby 
suspended, and this Act take effect and be in force 
from and after its passage, and it is so enacted. 

It is declared that deviate sexual intercourse, intimate 
sexual contact, and sexual contact as defined in Section 
21.01 of the Texas Penal Code, as amended hereby, be- 
tween persons of the same sex, is against the public 
policy of this State, iruismuch as such acts are the means 
for the transmission of diseases which threaten the health 
of the public at large, inasmuch as such acts threaten the 
public safety through their frequent association with 
violent conduct, inasmuch as such acts lead to and result 
in further acts against the policy of the State, and inas- 
much as such acts constitute, contribute to and promote 
immorality and indecency. 

It is further declared the public policy of this State to 
discourage and to refrain from encouraging or promoting 
(to the full extent of this State 's constitutional power to 
do so) the promotion of the practice of said sexual 
practices (deviate sexual Intercourse, intimate sexual 
conduct, and sexual conduct} between persons of the 
same sex and to discourage and to refrain from encour- 
aging or promoting (to the full extent of this State's 
constitutional power to do so), the placing of persons 
who promote or engage in said sexual practices between 
persons of the same sex in positions of public trust (in- 
cluding, but not limited to. positions as public school 
teachers, food handlers or processors, health care practi- 
tioners, public safety officers or any other position cf 
public leadership or responsibility) . 

The agencies, pobtical subdivisions, officers, em- 
ployees, schools, colleges, universities and other mstru- 
mentalities of this State or of its political subdivisions 
are hereby directed to comply with the pubbc policy of 
this State as set forth in Section 7 of this Act. The At- 
torney General, all district attorneys, City attorneys and 
law enforcement officers of thjs State are hereby 
authorized and directed to defend the constitutionality 
of this Act, to enforce this act and the public policy ex- 
pressed herein, and to defend this State and the agencies, 
political subdivisions, officers, employees, colleges, uni- 
versities, and other instrumentahties of this State or its 
political subdivisions in their actions in support of the 
pubbc policies of this Slate as expressed in this Act. This 
Act shall be liverally construed to carry out these 
objectives and purposes. 



204 



ACTION ALERT! 

This is happening to you... 

THE BILL ON THE OTHER SIDE OF THIS SHEET HAS BEEN INTRODUCED 

IN THE TEXAS HOUSE OF REPRESENTATIVES BY BILL CEVERHA OF RICHARDSON. 

IT IS NOW BEING CONSIDERED BY THE CRIMINAL JURISPRUDENCE COMMITTEE. 

WHAT YOU CAN DO 



YOU CAN HELP US DEFEAT THIS ATTEMPT TO INVADE THE PRIVACY OF ALL 

TEXANS BY WRITING LETTERS TO THE FOLLOWING CRIMINAL JURISPRUDENCE 

COMMITTEE MEMBERS: 

Wayne Peveto -- chair 

Tom Waldrop 

Terral Smith 

Dick Burnett 

Al Granoff 

Joe Hernandez 

Sam Hudson 

James Hury 

Debra Danburg 

An example letter would be (do not copy exactly since 
legislators do not respond well to form letters. Use personal 
stationery, not an organization's letterhead): 



April , 1983 



The Honorable ^_^ 

Texas House of Representatives 
P.O. Box 2910 
Austin, Texas 78769 

Re: House Bill 2138 

Dear Representative 



I understand that you will be considering the above 
bill since you are a member of the House Criminal Jurisprudence 
Committee. I urge you to oppose this bill because it represents 
a major invasion of the privacy of all Texans. 

Consensual sexual behavior between adults in private is 
of no concern to the State of Texas. 

(At this point, although it is not necessary, you may want to 
add your personal reasons for objecting to the bill. Keep it short 
and to the point) 

Thank you for your consideration. 

Sincerely yours, 

15) Don't delay; Write now |^ 



205 



PO Box 3045 
Houston. Texas 77253 
(713) 529-0504 



Committee for Public Health Awareness 



The purpose of this organization is to increase public 
awareness of health issues. Achievement of this goal 
will come through education of people as individuals and 
as groups in business, professional organizations, pri- 
vate institutions, and government agencies. Local, state, 
and national governments will also be lobbied on specific 
health issues to provide adequate research funding and 
necessary health services for all citizens. 

The following projects will also be used to futher public 
health awareness i 

Educational forums. 

Electronic media programs. 

Petition drives and letter campaigns. 

Briefing of political leaders. 

Lobbying for health related legislation. 

Document deviation from standard policy by agencies. 

Networking with other health related organizations. 

Our funding is from donations and projects are implemented 
as funding becomes available. If you are interested in 
participating or have resources or helpfull contacts, 
please fill out a membership card. Public health is every- 
one's responsibility. 



26-097 O— 83 14 



206 

Mr. Weiss. Mr. Collins. 

STATEMENT OF CHRISTOPHER J. COLLINS, COOPERATING 
ATTORNEY, LAMBDA LEGAL DEFENSE AND EDUCATION FUND 

Mr. Collins. Mr. Chairman and representatives of the subcom- 
mittee, I am Christopher J. Collins, a cooperating attorney with 
Lambda Legal Defense and Education Fund. Lambda is a national 
nonprofit, tax-exempt organization whose primary goal is to pro- 
mote and protect the civil rights of lesbians and gay men through 
litigation. 

I am a member of the Committee on Confidentiality of the New 
York City AIDS network, and am director of the St. Mark's Clinic, 
a community health center serving the lesbian and gay community 
of New York City. 

The broad issue to be addressed by this subcommittee is how the 
Federal Government responds to the overall needs of disenfran- 
chised groups. Specifically, in this particular instance the issue to 
be addressed is the relationship of the Government to three disen- 
franchised groups in this country: gay men, Haitians and IV drug 
users, who are most directly affected by a disease known as ac- 
quired immune deficiency syndrome. 

The specific issue I wish to address concerns the treatment that 
is to be afforded confidential information that is submitted by 
these three groups to governmental agencies, both State and Feder- 
al, either as part of the Government's ongoing surveillance pro- 
gram of AIDS cases, or as a part of research conducted by the Gov- 
ernment or private institutions and researchers. 

How has the Government responded to the needs of gay men, 
Haitians, and drug users during this health emergency? 

What is it doing to combat the disease? 

And what information is the Government collecting from these 
groups and what does it intend to do with that information once it 
is collected? 

This last question, the question of confidentiality, is the subject 
of this presentation. 

For at least the past year, the Centers for Disease Control, 
through local health departments, has been collecting a vast array 
of information concerning patients diagnosed with AIDS, under the 
pretext of doing epidemiological surveillance. This surveillance 
report requests information relating to specific conditions and op- 
portunistic infections, other infections, signs and symptoms prodro- 
mal to AIDS, diseases or conditions preceding or coexisting with di- 
agnosis of AIDS, medical immunosuppressive therapy and labora- 
tory and hospital data. 

In addition, the surveillance report requests the following infor- 
mation: 

(1) Name. 

(2) Date of birth. 

(3) Residence. 

(4) Occupation. 

(5) Marital status. 

(6) Living arrangements. 

(7) Immigration status. 



207 

(8) Parents' origin of birth, 

(9) The use of needles for injection of nonprescription drugs. 

(10) Sexual orientation. 

(11) Pregnancy. 

(12) During the previous 5 years preceding diagnosis of AIDS. 

(a) Sexual history of the patient, including specific sexual prac- 
tices. 

(b) Did the patient receive the hepatitis B vaccine, hepatitis B 
immune globulin, other immune globulins, factor VIII concentrate, 
cryoprecipitate, factor IX concentrate, blood transfusion. 

(c) Was the patient in jail or serving a jail term. 

The concern of the gay community is what happens to this infor- 
mation once it is collected, what is done with this information, who 
has access to it and what can be done to insure that access to that 
information is adequately restricted and protected from disclosure 
to unauthorized personnel. 

The obvious reason for this concern is that the Government, spe- 
cifically the CDC, is utilizing a surveillance report which requests 
information that in many States is still considered illegal and 
would compromise and/or jeopardize the needs of a person with 
AIDS. 

For instance, in Tennessee, homosexuality is still considered a 
crime which carries with it a penalty of imprisonment for a period 
of tirne not to exceed 1 year. In other States, the use of nonpre- 
scriptive intravenous drugs is illegal. 

Many Haitians are in this country illegally, which simply compli- 
cates the reporting problem further. The paranoia among the gen- 
eral population amidst cries for quarantine and imprisonment by 
fringe factions in this country have further added to the need for 
special protection of this information to insure that it will not be 
used in the future to satisfy some purely arbitrary need of one or 
more third parties. 

Until recently, the information that has been collected on per- 
sons diagnosed with AIDS, together with the information identify- 
ing those persons, has been turned over by most local health de- 
partments to the CDC. The CDC, in turn, on at least three separate 
occasions, has released a list of names identifying those individuals 
diagnosed as having AIDS to the New York Blood Center, a private 
institution regulated by the Office of Biologies of the Department 
of Health and Human Services, to certain individuals involved in 
the so-called Los Angeles cluster study and, most recently, the CDC 
has released its national list of people with AIDS by mistake to the 
New York City Department of Health. 

In addition, until recently, the CDC regularly released the names 
of people with AIDS in each State to that State's health depart- 
ment, as well as a specific city-wide list to the New York City 
Health Department. The CDC must take responsibility for its ac- 
tions in releasing those lists to unauthorized personnel. 

We believe that the release of the information to the New York 
Blood Center by the CDC was and is a violation of Federal law. The 
apparent justification for this last ongoing breach of confidentiality 
was that a comparison of national AIDS lists with a list of those 
who participated in the New York Blood Center's program for the 
development of the hepatitis B vaccine would be useful in deter- 



208 

mining any possible correlation between hepatitis B and AIDS. 
Whether or not this is so, this example raises a number of impor- 
tant questions. If the CDC is willing to turn over confidential infor- 
mation to a nongovernmental agency, can we safely assume that 
they will not make this same information available to governmen- 
tal agencies? 

Moreover, once that information has been released to a private 
institution, there is no longer any control over that information 
and its subsequent distribution. We view these breaches of confi- 
dentiality with the utmost gravity and suggest that these are the 
precise reasons why the present surveillance system cannot contin- 
ue in its present form, and why there is a special need for legisla- 
tion to protect records and information collected by the Govern- 
ment on these groups. Our concern is that further use of the cur- 
rent surveillance report may lead to additional leaks. 

The current system of reporting has likely resulted in significant 
underreporting of cases by physicians and institutions who simply 
do not trust the procedures that are presently in place to maintain 
patient confidentiality. Physicians, wary of their obligation to 
maintain physician/patient confidentiality, are loath to report 
cases of AIDS when they know that confidentiality cannot be main- 
tained. 

Patients, some of whom may be very ill, refuse to seek medical 
assistance for fear that they might be deported, considered gay, 
fired from their jobs, or irrationally tagged with the stigma of 
having a disease. It is conceivable that false information is being 
collected on patients too fearful that they will lose their jobs or, 
worse yet, to be quarantined or isolated by the Government. 

These are very serious issues that are confronting the CDC and 
the medical profession which will not go away. They must be ad- 
dressed, and adequate assurances must be provided to instill confi- 
dence and trust that patient records will be secure from disclosure 
to third parties for whatever reason absent that patient's consent. 

What we would propose at present — we have suggested that a 
statute be enacted, legislation be enacted to protect that informa- 
tion that is obtained from these patients, not be disclosed to third 
parties for arbitrary reasons. 

It has been acknowledged today that identifying information is 
arguably needed for followup study, for further research, for com- 
parisons. And no one is objecting to that possibility. In that event 
the need to protect the identifying information though is essential. 
We propose that new legislation be enacted in the form we have 
attached with my statement, which is designed to protect the confi- 
dentiality of information collected by the Federal Government 
acting on its own or through local governmental agencies or insti- 
tutions. 

Such a statute is based in part upon prior legislation that has 
been adopted by Congress to protect the confidentiality of patient 
records of participants in federally funded drug and alcohol abuse 
programs. 

Under the proposed legislation, records of the identity, diagnosis, 
prognosis, or treatment of any patient which are maintained in 
connection with the performance of surveillance research of AIDS 
conducted, regulated, or directly or indirectly cited by any depart- 



209 

ment or agency of the United States shall be confidential, and 
would only be disclosed under certain limited exceptions spelled 
out in the statute. 

The legislation would provide that the information could only be 
disclosed in one of three ways, pursuant to the patient's consent; 
where written consent is not forthcoming the information could be 
disclosed only to researchers and only so long as the identifying in- 
formation will be protected by those researchers. And where writ- 
ten consent — the third possibility would be where written consent 
has not been obtained, the information could be disclosed only if 
authorized pursuant to court order or upon a showing of good cause 
and pursuant to prior notice to the subject or participant. 

The proposed legislation would provide further that in no event 
may the information be used to initiate or substantiate any crimi- 
nal charges against the patient or to conduct any investigation of a 
patient. 

The need for legislation of this type is apparent given the long 
history of abuse that we have seen. The need is heightened by the 
nature of the disease and the groups principally affected by this 
disease, and we would urge its passage. It is respectfully submitted 
that confidentiality of records regarding AIDS patients and AIDS 
research is a very serious problem which must be addressed 
promptly. 

The bottom line is simple. We support and encourage research. 
However, the Government must demonstrate that it is capable of 
conducting that research in such a manner that it will protect and 
not jeopardize the health of the human subject or the research par- 
ticipant. Its failure to do so will continue to result in inaccurate 
reporting, falsified information, and a general mistrust of our Gov- 
ernment iDy all of its citizens. 

I thank you for your attention and consideration. 

Mr. Weiss. Thank you very much, Mr. Collins. 

[The prepared statement of Mr. Collins follows:] 



210 




LAMBDA LEGAL DEFENSE & 
EDUCATION FUND, INC. 

132 West 43rd Street, New York. N\' 100; i 
212 94-»-9-+88 



ManiKin^E A no me y 
Abbv R Rubt-nffid Lsq 

Public F.iiucacion CiMirdinator 
Fjir.uj Mjher 

(lommiiirr iif Advisori 
Hrllj .AhiuL 1 sq 
( jficr H.it.lin I vq 
Mtrrill 1: tUrL It I sq 
M.Tr(.n Dubfrnwn. Ph D 
ianwi Hi-hmjn. Esq 
Ntal |..linM.n I-m) 
t-tiir^c Ttfiun lisq 
Willum I Thoni ILsq 

Board of Direciora 

(:..■( hairs 

N.iilul» R'-iLh.ll Isq 



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lvnuihl..( l»,.ni: Mm. Isq 

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MuhjllJ l-llcr^ F,sq 
Djvhl MUoln.n Esq 
l.lj.EU- N.^'^n. Esq 
(jr..lv.. H..pc: 
T..ni Rasmusscn. Eiq 
K.>sjlu< Kiihrer. Lw] 
RhMnil.) Rivcrj. Esq 
rirn Sihwjbcr. E*q 
Mjrk Turkel. Esq 



Statement of Christopher J. Collins, Esq. 

Cooperating Attorney, 

Lambda Legal Defense and Education Fund 



Presented to the Intergovernmental Relations 
and Human Resources Subcommittee of the 
Committee on Government Operations 
United States House of Representatives 
August, 1, 1983 



Mr. Chairman and Representatives of the Subcommittee j, I am 
Christopher J. Collins, a cooperating attorney with Lambda Legal 
Defense and Education Fund. Lambda is a national non-profit, 
tax-exempt organization whose primary goal is to promote and pro- 
tect the civil rights of lesbians and gay men through litigation. 
I am a member of the Committee on Confidentiality of the New York 
City AIDS Network and am Director of the St. Mark's Clinic, a 
community health center serving the lesbian and gay community of 
New York City. 



211 



I. The Problem 

The bcoad issue to be addressed by this sub-committee is how 
the federal government responds to the overall needs of disenfran- 
chised groups. Specifically, in this particular instance the 
issue to be addressed is the relationship of the government to 
three disenfranchised groups in this country — gay men, Haitians 
and IV drug users who are most directly affected by a disease 
known as acquired immune deficiency syndrome ("AIDS") . 

The specific issue I wish to address concerns the treatment 
that is to be afforded confidential information that is submitted 
by these three groups to governmental agencies — both state and 
federal — either as part of the government's on-going surveillance 
program of AIDS cases, or as a part of research conducted by the 
government or private institutions and researchers. 

How has the government responded to the needs of gay men, 
Haitians and drug users during this health emergency? What is it 
doing to combat the disease? And, what information is the govern- 
ment collecting from these groups and what does it intend to do 
with that information once it is collected? This last question — 
the issue of confidentiality — is the subject of this presentation. 

II. The History of the Problem 

For at least the past year, the Center for Disease Control 
("CDC") , through local health departments, has been collecting a 
vast array of information concerning patients diagnosed with AIDS, 
under the pretext of doing epidemiological surveillance. (Attached 
is a Case Report Form used by the CDC.) This "surveillance report" 
requests information relating to specific conditions and opportun- 



212 



istic infections, other infections, signs and symptoms prodromal 
to AIDS, diseases or conditions preceding or coexisting with diag- 
nosis of AIDS, medical immunosuppressive therapy and laboratory 
and hospital data. In addition, the "surveillance report" requests 
the following information: 

1 . name ; 

2. date of birth; 

3. residence; 

4. occupation; 

5. marital status; 

6. living arrangements; 

7. immigration status; 

8. parents' origin of birth; 

9. the use of needles for injection of non- 
prescription drugs; 

10. sexual orientation; 

11. pregnancy; 

12. during the previous five years preceding 
diagnosis of AIDS: 

a. sexual history of the patient, including 
specific sexual practices; 

b. did the patient receive the hepatitis B 
vaccine, hepatitis B immune globulin, 
other immune globulins, Factor VIII con- 
centrate, cryoprecipitate. Factor IX con- 
centrate, blood transfusion; 

c. was the patient in jail or serving a jail 
term. 

The concern of the gay community is what happens to this 
information once it is collected, what is done with this informa- 
tion, who has access to it and what can be done to insure that 
access to that information is adequately restricted and protected 
from disclosure to unauthorized personnel.* The obvious reason 



♦Serious thought must be given to whether or not this information 
is even essential or relevant to an understanding of AIDS. It is 
submitted that this "information" has little, if any, practical 
relevance in research relating to AIDS. Questions such as what 
is the sexual orientation of this patient raise issues that are 
subjective in nature and provide no hard basis for scientific 
study. What is the difference between homosexuality and bisexual- 
ity? 



213 



for this concern is that the government, specifically the CDC, is 
utilizing a surveillance report which requests information that 
in many states is still considered illegal and would compromise 
and/or jeopardize the needs of a person with AIDS. For instance, 
in Tennessee, homosexuality is still considered a crime which 
carries with it a penalty of imprisonment for a period of time 
not to exceed ■ tiffeaGtv -year^f In other states, the use of nonpre- 
scriptive intraveneous drugs is illegal. Many Haitians are in 
this country illegally, which simply complicates the reporting 
problem further. The paranoia among the general population amidst 
cries for quarantine and imprisonment by fringe factions in this 
country have further added to the need for special protection of 
this information to insure that it will not be used in the future 
to satisfy some purely arbitrary need of one or more third parties. 
(See The New Republic , August 1, 1983, "The Politics of a Plague," 
p. 18.) • 

Until recently, the information that has been collected on 
persons diagnosed with AIDS together with the information identify- 
ing those persons has been turned over by most local health depart- 
ments to the CDC. The CDC, in turn, on at least three separate 
occasions, has released a list of names identifying those individ- 
uals diagnosed as having AIDS — to the New York Blood Center (a 
private institution regulated by the Office of Biologies of the 
Department of Health and Human Services) , to certain individuals 
involved in the so-called Los Angeles cluster study and, most 
recently, the CDC has released its national list of people with 
AIDS by mistake to the New York City Department of Health. In 



214 



addition, until recently, the CDC regularly released the names of 
people with AIDS in each state to that state's health deoartment, 
as well as a specific city-wide list to the New York City Health 
Department. The CDC must take responsibility for its actions in 
releasing these lists to unauthorized personnel. 

We believe that the release of the information to the New 
York Blood Center by the CDC was and is a violation of federal 
law, 5 U.S.C.A. §552a(b). The apparent justification for this 
astounding breach of confidentiality was that a comparison of the 
national AIDS list with a list of those who participated in the 
New York Blood Center's program for the development of the hepa- 
titis B vaccine would be useful in determining any possible cor- 
relation between hepatitis B and AIDS. Whether or not this is 
so, this example raises a number of important questions. If the 
CDC is willing to turn over confidential information to a non- 
governmental agency , can we safely assume that they will not make 
this same information available to governmental agencies? Moreover, 
once that information has been released to a private institution 
there is no longer any control over that information and its subse- 
quent distribution. We view these breaches of confidentiality 
with the utmost gravity and suggest that these are the precise 
reasons why the present "surveillance" system cannot continue in 
its present form, and why there is a special need for legislation 
to protect records and information collected by the government on 
these groups. Our concern is that further use of the current 
surveillance report may lead to additional "leaks." 



215 



IH . Why Is Confidentiality an Issue ? 

The current system of reporting has likely resulted in sig- 
nificant underreporting of cases by physicians and institutions 
who simply do not trust the procedures that are presently in place 
to maintain patient confidentiality. Physicians, wary of their 
obligation to maintain physician/patient confidentiality, are 
loath to report cases of AIDS when they know that confidentiality 
cannot be maintained. 

Patients, some of whom may be very ill, refuse to seek medical 
assistance for fear that they might be deported, considered gay, 
fired from their jobs, or irrationally tagged with the stigma of 
having a disease. It is conceivable that false information is 
being collected on patients too fearful that they will lose their 
jobs, or worse yet, be quarantined or isolated by the government. 
These are very serious issues that are confronting the CDC and 
the medical profession which will not go away. They must be ad- 
dressed, and adequate assurances must be provided to instill confi- 
dence and trust that patient records will be secure from disclosure 
to third parties for whatever reason absent that patient's consent. 
IV. Surveillance vs. Research 

The present report used by the CDC is of questionable value. 
That is a question for this sub-committee and the medical profession 
and I only raise this issue to heighten the overall significance 
of the problem. 

Moreover, the need for this type of information by the CDC 
for its surveillance function is also questionable. On its face, 
the "surveillance report" is actually a research tool. In order 



216 



to undertake its arguably mandated duty of surveillance, the CDC 
has no need for accumulating the kind of data sought in the "sur- 
veillance report." Rather, it merely needs to know the number 
and type of cases that are being reported. 

If, however, the CDC is engaged in epidemiological research, 
then the information may possibly become more relevant. In either 
case, the need to protect the information that is solicited and 
obtained is apparent and must be resolved. 
V. Proposals 

1. Surveillance 

Where the information collected by the CDC emanates purely 
from the CDC's surveillance function, then we would propose that 
no identifying information be collected. It is that simple. There 
is no need for data identifying AIDS patients when the information 
is provided for strictly surveillance purposes. Accordingly, 
instead of collecting the information that is presently being 
accumulated, we would propose that the following information be 
collected: 

1. first, middle and last initials of the person 
diagnosed with having AIDS; 

2. birth date; 

3. place of birth; 

4. sex; 

5. race; 

6. diagnosis; 

7. onset of symptoms; 

8. date of report; 

9. reporter and telephone number of reporter; 
10. mother's maiden last name. 

We believe that identifying information can be properly safe- 
guarded at the site where the diagnosis of AIDS is made (e.g., 
hospital or physician's office). This adequately safeguards the 



217 



patient's right to privacy and alleviates physician's concerns 
regarding physician/patient confidentiality. At present, the 
health department in Washington, D.C, is requiring physicians to 
report only initials, date of birth, city of residence and report- 
ing physician in cases where there has been a diagnosis of AIDS. 
The precedent is there for this type of reporting and it should 
be implemented by the CDC nationwide. 

2. Research 

Where the information sought emanates from a research function, 
then identifying information is arguably needed for follow-up 
studies, further research, etc. In that event, the need to protect 
that identifying information is essential. We propose that new 
legislation be enacted in the form attached hereto which is designed 
to protect the confidentiality of the information collected by 
the federal government acting on its own or through local govern- 
mental agencies and institutions. 

Such a statute is based in part on prior legislation that 
has been adopted by Congress to protect the confidentiality of 
patient records of participants in federally funded drug and alco- 
hol abuse programs. (See 21 U.S.C. 11174.) Under the proposed 
legislation records of the identity, diagnosis, prognosis or treat- 
ment of any patient which are maintained in connection with the 
performance of surveillance or research of AIDS conducted, regu- 
lated, or directly or indirectly assisted by any department or 
agency of the United States shall be confidential and would only 
be disclosed under limited circumstances. (See subsection (a) of 
the proposed legislation which is attached.) The legislation would 



218 



provide that the information could only be disclosed in one of 
three ways: (1) pursuant to the patient's written consent, (2) 
where written consent is not forthcoming, the information could 
be disclosed only to researchers and only so long as the identify- 
ing information has been removed, and (3) where written consent 
has not been obtained, the information may be disclosed only if 
authorized pursuant to a court order upon a showing of good cause. 
(See subsection (b) of the proposed legislation.) 

The proposed legislation would further provide that in no 
event may the information be used to initiate or substantiate any 
criminal charges against a patient or to conduct any investigation 
of a patient. (See subsection (c) of the proposed legislation.) 
Severe penalties would be authorized for any violations of the 
legislation. Finally, the legislation would require that the 
Secretary of Health and Human Services consult with the heads of 
other agencies affected by AIDS to promulgate regulations designed 
to carry out the purposes of this legislation. The Secretary 
would be required to -prescribe regulations establishing procedures 
to insure that all surveillance and research be carried out only 
with the full and informed consent of the patient or subject. 
(See subsection (f) of the proposed legislation.) 

The need for legislation of this type is apparent given the 
long history of abuse by the federal government in this area. 
The need is heightened by the nature of the disease and groups 
principally affected by the disease. We urge its passage. 



219 



CONCLUSION 



It is respectfully submitted that confidentiality of records 
regarding AIDS patients and AIDS research is a very serious problem 
which must be addressed promptly. The bottom line is simple: we 
support and encourage research. However, the government must 
demonstrate that it is capable of conducting that research in 
such a manner that will protect and not jeopardize the health of 
the human subject or research participant. Its failure to do so 
will continue to result in inaccurate reporting, falsified informa- 
tion and a general mistrust of our government by all of its citizens, 
Thank you for your attention and consideration. 



220 



PROPOSED STATUTE ON 
CONFIDENTIALITY OF PATIENT RECORDS 

Disclosure authorization 

(a) Records of the identity, diagnosis, prognosis, or 
treatment of any patient which are maintained in connection 
with the performance of any surveillance or research of 
AIDS (Acquired Immune Deficiency Syndrome) conducted, 
regulated, or directly or indirectly assisted by an depart- 
ment or agency of the United States shall be confidential 
and be disclosed only for the purposes and under the cir- 
cumstances expressly authorized under subsection (b) of 
this section. 



Purposes and circumstances of disclosure affecting consenting 
patient and patient regardless of consent 



(b) (1) The content of any record referred to in sub- 
section (a) of this section may be disclosed in accordance 
with the prior written consent of the patient with respect 
to whom such record is maintained, but only to such extent, 
under such circumstances, and for such purposes as may be 
allowed under regulations prescribed pursuant to subsection 
(f) of this section. 



-1- 



221 



(2) Whether or not the patient, with respect to whom any given 
record referred to in subsection (a) of this section is maintained, 
gives his written consent, the content of such record may be disclosed 
as follows: 

(A) To qualified personnel for the purpose of conducting 
scientific research, management audits, financial audits, or program 
evaluation upon 30 days prior written notice to the patient at his or 
her last known address, but in any event, such personnel may not 
identify, directly or indirectly, any individual patient in any report 
of such research, audit, or evaluation, or otherwise disclose patient 
identities in any manner. 

(B) If authorized by an appropriate order of a court of competent 
jurisdiction granted after appiclation showing good cause therefor. 
The patient or research subject should be afforded a reasonable op- 
portunity to participate in, or object to, the application. In assessing 
good cause the court shall weigh the public interest and the need for 
disclosure against the injury to the patient/research subject, to the 
physician-patient relationship, and to the treatment services. Upon 
granting of such order, the court, in determining the extent to which 
any disclousure of all or any part of any record is necessary, shall 
impose appropriate safeguards against unauthorized disclosure. 



-2- 



26-097 0—83 15 



222 



Prohibition against use of record in making criminal 
charges or investigation of patient 



(c) No record referred to in subsection (a) of this 
section may be used to initiate or substantiate any criminal 
charges against a patient or to conduct any investigation of 
a patient. 



Continuing prohibition against disclosure irrespective 
of status as patient 



(d) The prohibitions of this section continue to apply 
to records concerning any individual who has been a patient, 
irrespective of whether or when he ceases to be a patient. 

Penalty for first and subsequent offenses 

(e) Any person who violates any provision of this section 
or any regulation issued pursuant to this section shall be 
fined not more than $5,000 in the case of a first offense, 

and not more than $10,000 in the case of each subsequent offense. 



-3- 



223 



Regulations; interagency consultations; definitions, safeguards, 
and procedures, including procedures and criteria 
for issuance and scope of orders 



(f) The Secretary of Health and Human Services, after 
consultation with the heads of other Federal departments and 
agencies substantially affected thereby, shall prescribe 
regulations to carry out the purposes of this section. These 
regulations may contain such definitions, and may provide for 
such safeguards and procedures, including procedures and 
criteria for the issuance and scope of orders under subsection 
(b) (2) (C) of this section, as in the judgement of the Secretary 
are necessary or proper to effectuate the purposes of this 
section, to prevent circumvention or evasion thereof, or to 
facilitate compliance therewith. The Secretary shall prescribe 
regulations establishing procedures to insure that all sur- 
veillance and research be carried out only with the full and 
informed consent of the patient or subject or, in appropriate 
cases a designated representative thereof. 



-4- 



224 



9 

10 



STATE OF NEW YORK 



8197 



1983-1984 Regular Sessions 



IN ASSEMBLY 

June 26, 1983 



larroduced- hy COMMrTTEE 01* ROEES — (ac request of M. of A. Ta! 
Bianchi, Siegel, Bragtnan, Catapano, D'Amaco, Daniels, Dugan, Ei 
Flanagan, Goldstein, Gottfried, Grannis , Harer.berg, Hevesi! Hil 
Jacobs, Jenkins, KoppeU, Lashar, Marchiselli, M. H. Miller, Murt^^^u-, 
Nadler, Newburger, Orazio, Passannante , PiUictere, Robles, Sanders! 
Schirnroinger. Serrano, Tsnko , Vann, Vertz, Vilsort, icvoli) -- read once 
and referred to the Committee on Health 

AN ACT to amend a chapter of the laws of nineteen hundred eighty-three, 
amending the public health law relating to acquired immune deficiency 
syndrome (AIDS), as proposed in legislative bill no. S. 5930, in rela- 
tion to further amending the public health law by creating the ac- 
quired immune deficiency syndrome inscicuta and r.a.kmg appropriations 
therefor 



Hi® Peocle of the State of NV.w York, represent: -10 m Sonare and Assem- 
bly, do enact as follows: 

1 Section 1. Sections two through eleven and section thirteen of a chap- 

2 ter of the laws of nineteen hundred eighty-three, amending the public 

3 health law, relating to acquired immune deficiency syndrome (AIDS) as 

4 proposed in legislative bill no. S. 5930, are R£PZALED, and a new sec- 

5 tion two is added to read as follows: 

6 § 2. 



The publ ic health law is amended by adding a now article twenty- 



7 seven-E to read as follows: 

8 ARTICLE 27 -E 
THE ACQUIRED I.MMUNE DEFICIE.NCY SYNDROME INSTITUTE 

Section 2775 . The acquired immune deficiency syndrome institute. 
H 2776. Powers and duties. 

12 2777 .'Research council. 

13 2778. Advisory council. 

1^ 2779. Reports by the commissioner. 

1^ § 2775. The acquired immune deficiency syndrome institute. 1. There is 

^^ hereby established within the department of health the acquired immune 

^ deficiency syndro me institute. The institute shall have the central 

EXPLANATION— Matter in italics (underscored) is new; matter in brackets 

( ] is old law to be omitted. 

LBD10759-IO-3 



225 



iO 



A. 8197 



1 responsibility for administering the provisions of this article and 

2- otherwise coordinating the state's policies with respect to acquired int- 

3 mtjne deficiency syndrome. "" ' 

^ 2. The commissioner shall appoint a director of the institute and may 

5 assign such personnel within the amounts- appropriated as is necessary to 

fy carry out tha provisions of this article. 

^ § 2776. Powers and duties. 1. The institute shall have the follow ing 

i powers and datiear , .- - .^-.„,.^., y.-.^ . - . ~ ~ ' 

I ill to deve lop and promote scientific investigations into the cause. 

preventi on, methods of treatment, and cure of the acquired diseases of 

'. 1 immtmosuppression; ~~ ~~ ' 

l^ W ^° develop' and, promote programs of professional education and 

'■^ trainin g and improvements in instrumentation as necessary adjuncts to 

14. sucb »c£encig£e fi itf ese igations- / ■- ■ "7""" - -,'„,■ ~~~" ' 

':? C*^) tg develop- and maint ain a clearing house within the department for 

■° information coll ected on acquired immune deficiency syndrome. including 

'^^ a catalog ue of the existing medical literature and the results of exis't- 

13 ing epidemiological studiesT ', ' ' ' 

■^ 1A5 to deve lop and promote an outreach campaign directed toward 

-^ targeted high ris k, populations to provide coordinated information 

-1 regarding the treatment and counseling programs and sources of financial 

~2 assistance available; and ' ~ ~ 

^^ to promote the availability of supportive services for affected 
persons. ~ ~ ~ ~~ 



2. Personal data in. any investigations, reports and information relat- 
ing thereto shall be kept confidential and be afforded all of the 



protecti ons provided bv the provisions of paragraph f|) of s-uodivision 
one of s ection two hundred si.x of the public health lau. The, institute 
may, h owever, from time to time publish analyses of such scientific in- 
vestiga tions in such a manner as to assure tnat the identities of the 
individuals concerned cannot be ascertained. 

§ 2777. Resear ch council. 1. There shall be established within the in- 
stitute a rese arch council composed of seven members to be appointed by 
the commissione r. The members shall be representative of recognized cen- 
ters engaged in Che scientific investigation of acquired immunosuppres- 
sive diseasesT 

.1^ "H^e- rese arch council shall be ' responsible 'for making racommenda- 

tions to the inst itute for the purpose of carrying out the provisions of 
paragraphs (a) and (h) of subdivision one of section- twenty-seven hun- 
dred seventy-six of this articleT ~ "~ 

3. The council s hall meet at least four times a year. Special meetings 
may oe called bv th e chairman, and shall be called by hiar at the request 
of the commissioner. ~ ' 

^ — The memb ers of the council shall receive no cc -.pensation for their 
services. but«sh all be allowed their actual and necessary e.xpenses in- 
curred in the performance of their duties hereunder. 

§ 2778. .Advisor-/ council. 1. There shall be established within the in- 
stitute an advis ory council composed of thirteen members who shall be 
appointed irr the following manner: two shall be appointed by the tem- 
porary presiden r of the senate and one b» the minority leader of the 
senate: two shall be appointed bv the speaker of the assembly and one by 
the min ority leader of the assembly; seven shall be appointed by the 
governo r. The governor shall designate the chairman of the advisory 
counci l. The members of the council shall be representative of the pu- 
blic. educacion a-L and medical insti.tutions, local health, departments and 



226 



A. 8197 

1 nonprofit organizations, including organizations providing servicas to 

2 high risk populations. 

3 Z. The advisory council shall be responsible for advising the commis- 

4 sioner with respect to the- implementation of this article and shall make 

5 recommendations ta thfe institute for the purpose of carrying out the 

6 provisions of paragraphs (e) . (d) and (e) of subdivision one of section 

7 twenty-seven hundred seventy-six hereof. 

8 3. The council shalX meet at least four times a* year. Special meetings 

9 may ba called, by the- chairman, and shall be called by him at the request 

10 of tha commissioner. 

11 A-. The members of the council shall receive no compensation for their 

12 services, but shall be allowed their actual and necessary expenses in- 

13 curred in the performance of their duties hereunder. 

1^ § 2779. Reports by the commissioner- That commissioner shall orake a 

15 Fxrsir preliminary report tot the governor and the legislature of its 

16 findings, conclusions, and recommendationa not later than December 

17 first, nineteen hundred eighty-three, a second preliminary report of its 

18 findings, conclusions and recommendations not later than .March first. 

19 nineteen hundred eighty-four and a final report of its findin:;s. conclu- 

20 sions and recommendations not later chan >:arch first, nineteen hundred 

21 eighty-five, and shall submit with its reports such Legislative prcoo- 

22 sals as it deems necessary to implement ics recommendations. 

23 § 2. Such chapter of the laws of nineteen hundred eighty-three is 

24 amended by adding a new section three to read as follows: 

25 § 3. The sum of four million five hundred thousand dollars 

26 ($4.500 .000) , or so tnuch thereof as may be necessary, is hereby aporo- 

27 priated to the department of health from any nionevs in the ttat : tre.as- 

28 ury in the general fund to the credit of the state purposes account net 

29 otnen,rise appropriated for the purpose or entering into contracts cor 

30 research and for necessary costs of administration in ralation to pi n- 

31 graphs (a) and (b) of subdivision one of section twentv-seven hundred 

32 seventv-six and sections twenf .'-sevcin liur.dred seventy-sqven and f.-entv- 

33 seven hundred seventy-eight of the public health law, as added by sec- 

34 tion two of this act. No moneys shall be available for e.xoenditure for 

35 this appropriation until a certificate of aoncoval has been issued bv 

36 the director of the budget and a cooy of such certificate or any amond- 

37 ment thereto has been filed with the .state comptroller, the chai rman of 

38 the senate finance committee and the chairman of the assembly ways and 

39 means committee. 

^0 § 3. Section fourteen of such chapter of the laws of nineteen hxindred 

41 eighty-three is amended to read as follows: 

42 § [14.] 4. The sum of [three] si.x hundred [fifty] thousand dollars 

43 [(?350,000)] ($600,000) . or so much thereof as may "be necessary, is 

44 hereby appropriated to the- department of health out of any moneys in the 

45 state treasiiry in the general fund to the credit of the state purposus 

46 account and Hot otherwise appropriated, for contracts with nonprofit 

47 community organizations for programs designed to alert and educate the 
8 populations at risk, and the general public about the nature of the ac- 
quired immune deficiency syndrome (AIDS) crisis; providing patient sup- 
port services [including], which may include , but need not be limited to, 

51 the operation of a hoc line, [maintenance of ]. crisis laterventiott 

52 [units] services , home attendant [teams] services , legal [aid units] as- 

53 sistance and ameliorative and. supportive therapies. 

5^ § 4.. Section twelve of such chapter of the laws of nineteen hundred 

55 eighty-three is amended, to cead. as. faIlou&; 



49 
50 



227 



A. 8197 



L § [12) 5. The sum of one hundred fifty thousand dollars (5150,000), or 

2 so much thereof as may be necessary, is hereby appropriated to the 

3 department of health from any moneys in the state treasury in the gen- 
^ eral fund to tha credit of tha. state purposes account not otherwise ap- 

5 propriated ta establish,, ptomota and maintain a. public information pro- 

6 gram regarding: the acquired immune, deficiency syndrome (AIDS) for the 

7 purpose oil providing [educacional,.] outreach, health and counseling ser- 

8 vices for the general public, heaJ.th, professionals, and targeted higit 

9 risk populations. Na moneys- shall be available for expenditure from this 

10 appropriation until a certificate of approval has been issued by the 

11 director of the budget and_a copy of such certificate or any amendment 

12 thereto- has been filed with the state comptroller, the chairman of the 

13 senate finance committee and the chairman of the assembly ways "and means 

14 committee. ^ .„ , ^ 

15 » S:. SecEiott. fifteeir of socfr chapter- ot the laws- off nineteen hundretf 
IS eighty-three is renumbered section six. 

17 § 6^ This act shall take effect on the same date as such chapter of 

18 the laws of nineteen himdred eighty-three takes effect. 



228 



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229 



DATE or REPORT 



]nii 



Hooch Diy 

STATUS OF THIS REPORT 

LJ New case [JUpdate report 

I. 8ASIC PATIEKT IKPORMATIOH 

PATIEOT'S RAME 



DEPARTMENT OF HEALTH AND HUMAN SERVICES 
njaLic MCALTH scnvicc 

CCNTCMS POn Oftf ASf CONTMOL 
ATLANTA. OCOKOI* 30333 

ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) 
CASE REPORT 



CDC CASE REPORT HUmE» 



n 



STATE/LOCAL CASE 
REPORT mjMBER 



DATE OF BIRTH 



ACE AT DIAGNOSIS AIDS 



Month Day Tear Teara 

RESIDEHCE AT OHSET OF ILLHESS SUCCESTIVE OF AIDS 



— TTTk 

SEX 
□ Feaale 



Halden/Other 



aniTi 

RACE/ETHIIIC ORIGIN 

lJUt<lce □p(sIan7RcTTIc~TaIan3er 

Q Black rjAaerican Indlan/Alaakan Native 

la patient oiHlapanlc (Latin American) 
origin? DTes Q •*> 



CTty 

CDIIHENT CONDITION/ FROCHOSIS 
(_! Outpatient /aabulatory 
Q Hospl tallzed, not critical 
QHoapltalized. critical 
QDead 



County 
ir OCAO, date OF DEATH 



State/iCountry) Zip Code 

ADTOtSY fCTPORHED? 



D'" n*" 



Day 



Year 



II. specific CONDITIONS AND OPPORTUNISTIC INFECTIOU S MOST F REqUliWTLT ASSO C IATED MITH AIDS 

Check all that apply, indicate anatonlc site If appropriate, and give dace 
of diagnoais or apeciaen collection and the (tost specific or reliable aethod of diagnosis used 
(write it) code number from Hat at bottom of page)* 



DATE OF SPECIMEN 
OR DIAGNOSIS 



METHOD OFt 
DIAGNOSIS 



Kaposi's Sarcoma (check all anatomical aitea that apply) 
D Lymph Nodea Q Mouth/ ftiarynn □ Skin 

Q Anus/Rectum Q Internal Organa* Q Other* 



ujcn D 



♦specify site 



D 
D 



BteuntocysClfl carlnl 1 pneuaonla 



ToxoplaatBosli , encephalitis or brain abacess 

Atypical (non-tuberculous) HycobscCerlal Infection (symptoiutlc 
dlsaeiBlnated, e.g. bone narrow or iiultlple organ involvenenc) 
Q M. avluo-lntracellulare Q Other species* 

•Specify species 



nucD n 
nncD D 



a 

D 



D 
D 

O 



Candida esophagltis (Candida Infectiona at others sites 
nay be reported on ftge 2) 



Cryptosporldlosls with chronic diarrhea (persisting > 1 month) 

Cytonegalovlrus infection* (synptooatlc dlaseainsted, 

especially with docuaented patholo^ of lungs. Intestine; 
exclude oononucleosls syndrove) 






♦specify site(s) 



Cryptococcal infection: 



t Henlngltls 



Herpes aloplex Infection, chronic ulceration (persisting >l aonth) 
Specify sltefs)^ . 

Progressive nultl focal leukoencephalopathy 
(ftpovavirua Infection, brain) 



nn a 



D 



CDC USE 
City 


1 




County 








State 


1 


Sites 












Species 


1 




Sites 






1 




1 




Sites 














1 



t METHODS OF DIAGNOSIS : (Not all aechods are appropriate or acceptable for all diseases) 

1 • Microscopy: cytology, histology 4 - Serology: Antibody titer, any technique 7 ■ X-ray, fluoroscopy, etc. 

2 • Culture/nlcroblologlc techniques 3 ■ Antigen detection, any technique 8 • Ultrasound* CAT scan, etc. 

3 " Endoscopy: bronchoscopy, 6 - Physical exaainatlon 9 ■ Unknown 

slgaoldoscopy, etc. 



230 



OTH£R OPPORTUNISTIC INFECTIONS AMD CANCERS , soae ol which are listed below, uy be aaaoctated with AIDS. In the 
following spaces, Uac these or other diseases the patient has had, the site of occurrence, the date of diagnosis or 
speclaen collection, and the aost specific or reliable method of diagnosis used (use code nuaber froa list below>. 



o TuberculoBls, especially severe or dlsaeninated (e.g.. Involving liver, marrow) 

o Nocardla Infection (Nocardiosis) 

o Coccidloldes Infection (Coccldloldonycoalfl) 

o Lynphoma or retlculua cell sarcoma Involving the brain only 

o Burkltt's lynphona 

o Diffuse, pleomorphic, undifferentiated, non-Hodgkln*a lyaphoaa 



PATHOCEN/ DISEASE 



AfmOWIC SITE 



DATE OF SPECIMEN 
OB DUCNOSIS 



METHOD opt 
DIAGNOSIS 



LULU D 



on 



n 



_ nmin d 



fNot all aetbodB mre •ppfoprljite or •cecptable for *11 dl««i»««) 

cytoloRr. histology 4 - Scrolony: Antibody titer 7 • X-r«T, f luorotcopy, ■ 

2 - Culture/mlrroblolodlc terhnlque* 5 - Antigen detection, •ny technique 8 • Ultr»«ound. CAT scan 

3 - Endoacopy: br on c Kob c opy . *■ " Biyilc«i *«««tn«tlon 9 • Uihnown 



tHETHODS OF DIAGNOSIS: 
I - Hlcr< 



oldnai 



ipy . 



in. INFECTIONS/CONDITIONS OCCURRING WITH Bin" NOT SPECIFIC FOR AIDS OR AIDS PRODROME 



Check all that have occurred: 

QAsebiasls, persistent 

□ Herpes alnplex, chronic or persistent vesicular Infection 

□Mouth/ Ftiarynx CDGenltal OAnal/Rectal 

□ Herpes zoster 

□Localised □Disseminated 

□ Candida Infection 

□ Colo/Rectal □oral/rtiaryngeal (thruah) 

□ Idlopathlc/Autolmnune throabocytopenlc purpura 

□ Aucolnnune heoolytlc anenla 

□ Nephrotic syndrome 

□ other (Specify) . 



□ ^tone 



□other 



□unknown 



IV. SIGNS/SWPrOHS PRODROMAL TO AIDS 

Check all Blj^ns/syoptome persistent at least one month before 

onset of a specific infectlon/diaease suggestive of AIDS. 

□ Fever 

□ Night sweats 
QMalalse/Fatlgue 

□ chronic lyaphadenopathy , > 3 non-contiguous sites 

□ Arthralgias /Myalgias 

□ Weight loss, unexpected, > 15 pounds or > lOZ normal body weight 

□ chronic diarrhea 

□ no pathogen/cauae Identified 

□specific pathogen/cauae Identified (Specify) 

□ persistent bone marrow dysfunction 

□ Leukopenia (<4300/m»3) □Lymphopenia (<1500/om5) 
□Thrombocytopenia (<IO0.0OO/™3) 



□ ^tone 



□ikiknown 



Pathogen/ Anatomic 
Disease Site 

IZJ ED 



ED n. 



CD 



Approximate Date Oiset 
First Slgn/Sympton 



□ other (Specify) 



V. DISEASES OR CONDITIONS FRECEDIHC OR COEXISTING WITH DIAGNOSIS OF AIDS 
Check sU that have occurred: nNone 

□ Leukemia 

□ Acute lymphocytic Ochronic lymphocytic □ Non-1 ymphocytlc 

□ hodgkln's disease 

□ Non-Hodgkln'a lymphoma 

□ Multiple myeloma 

S Diabetes melUtia. Inaulin-dcpendenC 
Renal failure, chronic 

□ Hepa c 1 1 i a , chron 1 c 

□ congenital looune deficiency syndrome (specify) 

□ Bleeding disorder/Clotting factor deficiency 



□ Unknown 



CD 



a Factor Vtll deficiency (cla.alcal Heaophllla) 
Factor IX deficiency 
Qother requiring factor replaceaent therapy (ap»clfy)_ 

Oother (apeclfy)^ 

CDC 59.3 f**^ 2 

nCV. 4-83 



CD 

en 

CD 



231 



VI. MEDICAL IMMUNOSUPntESSIVE THERAPY QNone CJlMknown 

During 3 nonths preceding diagnosis of AIDS, did patient receive (check all that apply): 

Qsystealc cortlcoiiteroida [jCytotoxlc cheaotherapy /other lataunosuppresslve therapy 

If ye*., did synptoas of specific Infectloua disease precede It^unosuppressl ve therapy? Qves [.jNo 

YII, SOCIAL AND RISK FACTORS (Check all that apply) 

Usual occupatlon(s ) of patient during last 5 years 



Marital Status: □ Never narrled QMarrled Qwidowed nS«P«rated Doivorced Ounknovn 

Living srrangenent of patient during year preceding diagnosis of AIDS: 

[^ Alone n^'ith spouse [~)with children ]~3with aale coBpanlon(s) Qwith fenale cofflpanlon(8) 

Month Tear 

Uaa patient born in U.S. (50 states)? ClYes □* If no. date of arrival In U.S. 1 I II i I 

If patient or either parent were bom outside U.S., what was country/territory of blrth/orlgln? 
QCanada □C"'>* □Dominican Republic [jHaltJ QHcxIco Qftierto Rico 

Qcanbodla/Vletnaa/Laos [jOther (specify country/terrttofy) 



Has the patient ever used needles for sel f-lnjectlon of non-prescrlptlon drugs? Qtes [J'** ffUnknown 

What Is the sexual orientation of this patient? 

QHeterosexual QHoowsexusl Qfllsexual [_jNone [ ] Unknown 

Was the patient pregnant while til with AIDS? LJYes LJno LJunknown LjNever Pregnant 

Has the patient delivered a live-born Infant during the last 5 years? LJYee Qno QLViknown 





CDC USE 
























1 











During the five years preceding diagnosis of possible AIDS, did this patient : 

Yes No Unknown 



Have sexual relations with a LJ [_] I ! 

aale partner ? _. _. — — 

o Have sexual relations with a 1 I LJ 1— J 

feaale partner? 

o Have sexual relations with a LJ LJ LJ 

person who now has AIDS? 

o Have close, non-sexusl contact PH PH LJ 

with a person who now has AIDS? _^ ^_^ — — 

o Receive hepatitis B vaccine? LJ I I LJ 

o Receive hepatitis B loaune n PI n 

globulin fHBio? rn rn rn 

o Receive other lirmune globulins? LJ LJ I I 

o Undergo heoodlalysls? LJ LJ LJ 



o Been In jail or served a 

prison tera? 
o Receive Factor Vlll 

concentrate? 
o Receive cryopreclpltate? 

o Receive factor IX concentrate? 

o Receive blood or pecked red 

cell transfusion? 
o Receive other blood conponents, 

e.g., platelets, plasoa, etc? 
o Donate blood? 

o Donate plasma? 



Yes No Unknown 

Dan 
D n D 
D D n 
a D D 

ODD 

ODD 
D D D 

D D n 



If patient has donated blood or plasm, what Is the name and 
address of the last or Boat frequently used donation center? 



ApproxlBiate date of last donation 



Nane of blood/plasma center 



City 



State 



Honth 



Day 



Year 



VITT. LABORATORY DATA : Reault-s before use of Immjnoauppresslve therapy (cytotoxic drugs, steroids) preferred. 
WHITE BLOOD CELL COUKT PERCENTACE LYNPHOClfTES PLATELET COUNT (Lowest value) Date of Laboratory Tests 



Honth 



Day 



Year 



T-LYMF«OCrrE SUBSET COUNTS: Dcheck If T-<:eIl studies not perfomed 

Qoeck If patient received eterolds/other laaBunoauppreaslve therapy during aonch before T-cell studies 



^rentage of Lymphocytes 

T-HELreR I p— j 

(OICT-4, >u-3) I I I I 



T-HELPER/T-SUPPRESSOR 
(T„/Ts) RATIO 



Percentage of Lynphocytes Date of T -Lynphocyte Tests 



Honth 



Day 



Year 



Interpretation of Th/Tj _, —^ 
ratio for this patient Is: [ |Nornal I (High | | Low 



Range of norsal valuea for T^/Ts ratio at this laboratory: HI 



gh norsal I L I low noraal I L I 



COC 59.3 
BCV. 4.B3 



232 



ADDITIONAL INFORMATION OR COMMENTS: 



or treataent of disease associated with AIDS or cellular Imnune deficiency conditions? 
nospl tal 



D 



HOSPITALIZED 



City 



MEDICAL RECORD NUMBER 



ADHISSION DATE 



1 1 1 1 1 1 1 1 1 g:;] qp qn 

Month Dsy Year 



1«. Name of person 

conplettng this fom 



Tltle/Rjslt ion/Special ty_ 
Instl cutlon/Address 



2. Person reporting this case 
(If different froa above) 



Title/ItosltIon/Speclalty_ 
Instl tution/Addreas 



Telephone ( ) 



Telephone ( ) 



niyalcian to contact to update Infornatlon about this patient (If different froa above): 

3. Nane: Telephone ( ) 



Tltle/R>8ltlon/Speclalt)r_ 
Instl tutlon/Address 



Other physicians who may provide Important Inforoatlon about this patient: 

4. Nsne: Telephone ( ) 



Tltle/R>sltion/Specislty_ 
Instl tutlon/Address 



Ext 



Telephone ( ) 



Title/n>sitlon/Speclalty_ 
Institution/Address 



FOR CDC USE 



Place of diagnosis resulting In Initial case report: 



Hospital 
Pora reviewer Date of forv review 

CD Cn CD [XI 

Month Day Year 



City 
Case Classlficatloa 

DD 



State 

Date of keypunch/ 
cooputer entry 



COC 59.3 
REV. 4.a3 



233 

MEW YORK STATE AIDS TASK FORCE 
INITIAL REPORT TO THE GOVERNOR 

• f* 

JUNE 21, 1983 



Submitted by: 

David Axel rod, M.D. 

Comm'ssioner of Health 

AIDS Task Force Chairman 



234 



CONTENTS 

1. AIDS: State Concerns 4 Responsibiliffes 

2. Current Information About AIDS 

3. Specific Task Force Agency Concerns and Recommendations 

— Department of Health 

— Department of Correctional Services 

— Commission of Correction 

— Department of Insurance 

— Division of Substance Abuse Services 

— Office of Mental Health 



235 



AIDS: State Concerns and Responsibilities 



The phenomenon of AIDS now looms as a major public health issue for 

government and science — because of the puzzle that it represents for 

researchers, the peril with which it threatens certain people, and the anxiety 
it generates in the populace. 

There are many questions which still lack answers. We know that AIDS 
primarily attacks intravenous drug users and homosexual males. But we don't 
know why. We don't even know if the syndrome represents a single disease 
entity. 

This report emphasizes the urgent need for answers to address the 
concerns of designated "high risk" groups, service workers who care for AIDS 
victims or potential victims, and society at large before fear overcomes 
reason. 

While AIDS may not compare to heart disease or auto accidents as a 
killer, it does represent a major and immediate challenge. The 
recommendations for action included in this report fall into four major 
categories of government responsibility: 

1. Civil Rights. There is a pressing need to act firmly and 
directly to protect the civil rights of persons v/ho are caught up in the AIDS 
fear that is spreading more quickly than the disease itself. Whole groups in 
our society are in danger of being needlessly ostracized and isolated. 
Haitians are being fired from their jobs for no reason other than their 
national origin, doctors are reluctant to treat patients, funeral directors 
are calling for a moratorium on full services for AIDS victims, and some 
voices in the popular press are suggesting that "God's revenge" is being 
visited upon certain members of our society. All state agencies, departments, 
boards, commissions and officers must avoid any prejudicial activity toward 
AIDS victims, their families, or the widely labeled "risk" groups. 
Furthermore, every available tool should be used to prevent such 
discrimination by others, primarily in the service industries. 

2. Education . Ignorance, fear and misinformation are threatening to 
overtake science and reason. This is partly due to an apparent opportunism on 
the part of some scientists, and the natural impact of heightened publicity. 
There is no credible scientific evidence, for instance, that what we connonly 
call AIDS is actually a communicable disease. Yet it is frequently being 
defined as an infectious or communicable disease, resulting in escalating 
fears about AIDS spreading through casual contact, on dinner plates, in 
prisons, on bed sheets,' on public transportation, and through blood 
transfusions. 

To allay public fears, to stop the increasing isolation of 
persons identified as members of risk groups, and to disseminate accurate 
information on this issue, we must expand and accelerate our current education 
efforts. Just as we have worked with the Corrections Department to address 
the concerns of employees and inmates, we must provide relevant factual 
information to other occupational groups, such as doctors, hospital v/orkers. 



236 



sanitation men, laundry workers, drug counselors and others. People need to 
understand that the only known routes of transmission are through homosexual 
activity and IV drug use, and that the risks outside those activities are not 
significant. We believe blood transfusions do not present a risk, but the 
public at large needs to learn and understand that fact, and many others. 

3. Treatment . The tragic victims of this disease are nainly young, 
largely male, and commonly suffer from months or even years of anxiety as they 
v/ait for an opportunistic infection to attack their defenseless bodies. 
Because of fear and prejudicial treatment, they may also suffer from 
isolation, loneliness, loss of job and income, as well as the disease itself. 
It is more difficult to protect such persons from the infections that threaten 
them when society's normal network of support services desert them. We also 
have a significant number of AIDS victims in our state institutions, and they 
need special consideration. 

Therefore, the state must inake a major effort to provide 
appropriate treatment facilities for all institutionalized AIDS victims, to 
care for them in a comforting setting that protects them as much as possible . 
from infection. And we must also use what authority and persuasive powers we 
have to assure that non-institutionalized AIDS patients are provided the care 
they need — the care v/e v;ould expect to be" made available to any victim of a 
debilitating disease in our society. Furthermore, the state should continue 
to support, and expand, counseling programs for victims and potential victims 
and their famil ies. 

4. Research . V/ith so much of what is now known about AIDS based on 
incomplete research reports, thumbnail sketches and inadequate data, there is 
a large gap in the scientific as well as popular understanding. 
Epidemiological questions about localized clusters of the disease, about drug 
use habits, about certain sexual practices, about the significance of the 
"risk groups" and the infections which strike them, all need investigation. 

As New York State is the unhappy host to roughly half the known cases, we have 
an ideal opportunity and a responsibility to pursue this research. 

A whole range of clinical issues also needs to be investigated. 
Research on the immune system, which is already going on in connection with 
other diseases, must be expanded to focus on AIDS directly. The two main 
types of infections striking AIDS Patients may have some relationship to 
different strains of AIDS, different ratios of iimune system actors in our 
bodies. The questions are numberless. 

The risk to the general population appears now to be virtually nil, 
for the percentage of cases outside the basic risk groups is remaining 
constant at approximately 5%, even as the caseload mounts. But that is small 
comfort to those unfortunate people who live with the knowledge that they are 
susceptible. We have a grave responsibility, as the home of half the known 
victims. But we also have the opportunity, as you said on June 17, "...to set 
an example for the nation..." in attacking AIDS. Without hysteria, but with 
reason; without anger, but with compa;ssion; without fear, but with honesty — 
we can serve well all the people of Mew York. 



237 



Current Information About AIDS 



nnn inSorJ^L*-^ ""* two years, a significantly increasing incidence of 
non-inherited immune suppression has appeared in the United "Jt^tpe anH <-^ c«™- 
extent in other countries. While the I'a'bel Acquired Ke Defici-ency 
Syndrome (AIDS) has been given to these cases, there is no defnitive evidence 

of etio'loov ""Tch'I'AVI"''' V'^l' '.'V^'' "''^^ ' common caJstfvr gent 
hL! I^;^' * *u°^ the current epidemiological and medical data, in fa!t 
does, not support the single disease concept. ' 



Medical data 



a^ thP oi been defined by the federal Centers for Disease Control (CDC) 

nPrJJnc u^^r'"'! °^ specific, rare opportunistic infections or cancer n 
persons w th no known cause for diminished resistance to these diseases Such 
diseases include Kaposi's Sarcoma (a previously rare cancer)- Pneumocvstis 
carinii pneumonia (previously seen only in the very elder?y or amZ Jit ents 
trt2V.ni f ^"^°t^^'-,^Py °^. ^unosuppressive therajy associa?ed w?fh organ 
transplants); or such serious opportunistic infections as central nerSoSs 

d^ rheaf?? n^«'^.'' ^'/'r'^'^l^^^'^ candidiasis, cryptococcal meni-ngUis. a 
diarrheal illness caused by Cryptosporidium and nontuberculosis 
cwn?i!n ?'"'°u'^ Unexplained combinations of prolonged fever, weight loss and 
SnJromel^""' ^ ""^ represent early foms or a mild variant i? the 

Laborator7 tests of AIDS victims indicate a significant reduction in the 
numbers of T helper lymphocytes (white blood corpuscles in the lymph Jl aids) 
n Lnf' r^'l'^y responsible for cellular immunity. Lymphocytes of AiSs 
.^nt n^n f/° -^"^ Srossly depressed proliferation response to mitogens and 
antigens (foreign matter) in the blood stream. "■' uuyens ana 

n=^,-. l^ ^^ noteworthy that the opportunistic diseases which affect AIDS 

b sS L7es°L'nd%'o'r'\'^'' 1° the various "risk" groups. Homosexual and 

!lnff^!l .■ }l . t° <^e^^1°P Kaposi's Sarcoma as the initial disease 

H^vlin I "' *^'"'3 "'^'" ^^"ctims. Haitians and hemophiliacs most frequently 

develop Pneumocystis carinii pneumonia as the most virulent and fatal ^"^"'^'^ 

both'cSSditiSns ''^'°"' '^ ^'^ '''^''"^' (approximately 10%) have developed 

rnr JJ"! ""k^ of AIDS is still unknown, although research is in progress at 
CDC and a number of medical centers across the U.S. Although all evidence 
indicates that the syndrome is not communicable through casual contact it 
does appear in persons who have intimate sexual contact or who have 
rp^!r;!.^h" repeated intravenous injections. This phenomenon has led some 
^!^n^ r\^° ^P^-^^l^te that the causative agent for AIDS may be a virSs 
norJjen\°sSl?;h':d\'- ''''''' " ''"^"^^'""^ ^Sent is actually involved has 



26-097 O— 83 16 



238 



Since the disease tends to affect specific groups and has not spread 
beyond these groups, some physical or environmental factor or factors common 
to the host (or victim) may be contributory or causatory to development of the 
syndrome. One hypothesis is that the immune system of AIDS victims may 
already be damaged or compromised in some way, thereby increasing certain 
Individuals' susceptability to the condition. We know, for example, that 
certain infections, including hepatitis B, are more common among IV drug users 
and active homosexuals than among the general population. A number of AIDS 
victims also had a previous history of sexually transmitted disease (including 
herpes, gonorrhea, etc.) and laboratory tests have confirmed antibodies in the 
blooci for hepatitis B and cytomegolovirus (CMV) among many of these victims. 

Epidemiologic data 

The national case summary issued by the Centers for Disease Control 
reports that nearly 95% of AIDS victims have been male, with more than 90% 
between the ages of 20 and 49. Based presumably on case histories provided by 
the victims, CDC has allocated approximately 71% of AIDS cases to the 
homosexual or bisexual "risk" category, and 17% to the intravenous (IV) drug 
use "risk" group. Approximately 5% of national AIDS cases have been reported 
among Haitian immigrants. A few persons with hemophilia, who are receiving 
pooled factor VIII concentrate therapy, have been diagnosed as having AIDS. A 
small number of cases nationally which currently do not appear to fall within 
these four risk categories are under investigation by CDC and local health 
agencies. 

AIDS cases presently are clustered in certain geographic areas, with 80% 
of cases concentrated in six metropolitan areas, primarily in New York and 
California. Approximately 50% of all AIDS cases have been reported from l.'ew 
York State. Nearly 90% of IV drug associated cases have been identified in 
the northeastern U.S., primarily New York and New Jersey. 

National incidence 

Through Kay 18, 1983,1,450 AIDS cases were confirmed nationally by CDC. 
Of these 558 had died, for a case fatality rate of 39%. 

Of the 1,450 confirmed cases, 26% presented with Kaposi's Sarcoma (KS), 
51% with Pneumocystis carinii pneumonia (PCP), 8% with both KS and PCP, and 
15% with other opportunistic infections (01) without KS or PCP. 

Cases occurred in whites (57%), blacks (28%), and Hispanics (14%). 
Major risk groups include homosexuals or bisexuals (71%), IV drug users (17%) 
and Haitians (5%). Eighteen AIDS cases have been reported in hemophiliacs: 
14 in the United States, 4 from overseas. CDC is also investigating 18 
possible transfusion related cases. 



239 



New York State -Incidence 

Through May 18, 1983. 700 or 18% of the total United States CDC reported 
AIDS cases were in New York State residents: 660 or 45S from New York City 
and 40 or 3S from Upstate New York. 

The epidemiologic features of New York State AIDS cases are determined 
from a statewide case registry in the Health Department which is updated on a 
monthly basis. Features of New York State AIDS cases are similar to United 
States cases in terms of: 

% Male 93J 941 

% Black 295 28« 

% homosexual/bisexual ' 73S 71% 

% aged 20-49 92% 912 

but differ in: 

■% White 50% 57S 

% Hispanic 21% 14S 

% with IV drug use 33% M% 

Of the 40 upstate New York AIDS cases reported by CDC as of May 18, 
1983, 21 occurred among inmates in State prisons. As of June 7, 1983, the 
State Health Department has reports of 36 confirmed AIDS cases among State 
prison inmates with 7 other possible cases under review. All evidence 
indicates that these inmates contracted AIDS prior to imprisonment. The 
syndrome is now thought to have an incubation period of up to two years and 
virtually all inmates with confirmed AIDS had a prior history of IV drug use 
in the tiew York City area prior to incarceration. New Jersey inmates with 
AIDS also have a history of drug use in New York City. New Jersey is the only 
other state reporting AIDS prison cases. 

If the prison inmate cases are removed from the upstate case total, as 
appears more appropriate, it is evident that AIDS is not a major disease 
entity in New York outside of New York City. 

Risk to the General Population 

At the present time there is no evidence that AIDS represents a risk to 
the general population. As indicated by the national case data, only S% of 
reported cases currently appear to fall outside of the identified "risk" 
categories. That percentage has held steady even as overall case reports 
climb. 



240 





no. cases 


% of total 


homosexual, bisexual 


1031 


71.0 


IV drug use 


248 


17.0 


Haitian 


75 


6.0 


hemophiliac 


. 12 


0.8 


*■ no apparent risk group 


83 


5.2 



I 



* These cases are still under study by CDC and state and local health 
personnel in an effort to discern potential risk factors. Some cases, 
initially reported "outside of the risk groups" have proven, upon further 
investigation, to fall within one of the risk categories. 

It is noteworthy that not a single case of AIDS has been reported among 
/-health personnel, laboratory personnel or funeral directors. While some 
infection control precautions are now generally taken with AIDS patients' 
blood samples and body fluids, there v/as an approximate tv/o year period before 
the syndrome v/as identified when AIDS patients' and laboratory specimens were 
handled in a routine manner. 

Secondary cases, involving potential non-sexual transmission to 
household members or close companions of AIDS victims, have not been reported. 

Based on all epidemiologic data to date, there is no evidence that AIDS 
Is transmitted through casual contact , including: 

— sneezing, coughing or spitting 

— handshakes or other non-sexual physical contact 

— toilet seats, bathtubs or showers 

— utensils, dishes or linens used by an infected person 
• — food prepared or served by an infected person 

— articles handled or worn by an infected person 

— being around an infected person, even on a daily basis over a 
long period of time. 

Blood Transfusion Risk 



Following intensive evaluation of all data by a special AIDS task force 
appointed in 1983, the New York State Council on Human Blood and Transfusion 
Services concluded that the risk of developing AIDS from blood transfusions is 
remote and that adequate precautions to safeguard the blood supply to the 
maximum extent possible are being taken. 

The following resolution was passed unanimously by the Council on June 
8, 1983: 

"Analysis of all the data collected to date has demonstrated no 
significant risk for recipients of blood or blood products for 
contracting the acquired immune deficiency syndrome (AIDS). Until 
further data now being accumulated can be evaluated, the added 
precaution being taken as a standard public health measure, is the 
voluntary exclusion of donors v/ho are at high risk for exposure to 
AIDS. Evaluation of the laboratory tests currently available has 
failed to demonstrate that any one test or combination thereof has 
proven to be more effective than those measures already in place." 



241 



More than 12 minion units of blood and blood components are 
administered to about 3 million people each year. There also are 
approximately 15,000 hemophiliacs in the U.S., each of whom has received 
frequent transfusions of pooled factor VIII, a blood clotting component which 
requires several thousand donors for each transfusion. 

There have been 14 cases of AIDS reported among hemophiliacs in the U.S. 
and fewer than 10 additional cases which are currently under investigation for 
a possible link to blood transfusions. In only one case (a California infant 
with a platelet deficiency) was CDC able to identify an AIDS victim as a 
donor. The remainder of the blood acquired from this donor was administered 
to other recipients v/ho did not develop AIDS. In addition, it is impossible 
to rule out congenital immune deficiency or immune system defects in the case 
of an infant. 

Risk Groups 

The reason for AIDS incidence among specific groups is not known. 
Outlined below is the known information potentially relevant to AIDS case 
identification among the various "risk" groups. 

Drug Users : Virtually all AIDS victims who report intravenous drug use 
are from the northeastern U.S., primarily Hew York City. There is very little 
incidence of AIDS among lY drug users on the West Coast. It is presumed at 
this time, that AIDS case finding among IV drug users is related to sharing or 
re-using dirty needles, since Hepatitis B can be transmitted from 
person-to-person through this route. It is of note, that the Office of Drug 
Abuse reports that there are known "shooting galleries" in the New York City 
area where drug injection paraphernalia may be rented and that such equipment 
is not discarded or disinfected after each use. 

One research group has published a study indicating that children born 
to IV drug user AIDS victims may have contracted the syndrome. . The 
researchers acknowledge that the diagnosis of AIDS in these children is not 
confirmed, and that congenital immune defects and deficiencies are sometimes 
present in young children. All children involved in this study developed 
symptoms of immune deficiency within the first two years of life, generally 
within the first year. This may indicate that the condition was congenital or 
that AIDS may be acquired simultaneously by the mother and child across the 
placenta during gestation or through blood comingling at the time of birth. 

Homosexual & bi-sexual men : Nearly 75 percent of AIDS cases occur in young 
men (ages 20-40) who acknowledge homosexual or bi-sexual activity. These 
cases are clustered in big cities (New York, San Francisco, Miami, Los 
Angeles) where large gay communities exist and sexual contact among strangers 
is readily available. A large percentage of the homosexual and bi-sexual AIDS 
victims report multiple sexual contact in "gay bath houses" or other "gay pick 
up" type facilities or clubs. 



242 



One CDC researcher in California was able to link 40 homosexual AIDS 
patients as having had sexual exposure to at least one other case. Of the 27 
cases for which detailed information was available, 81. 5S of the men were 
reported to have engaged in a sexual practice involving rectal trauma during 
the year before they fell ill. The practice, called "fisting" involves the 
insertion of a portion of the hand, or even the entire fist into the anus of 
another person. The males in this study also appeared to be very sexually 
active. The 27 men had a median of 120 sexual partners (50 percent of whom 
were strangers) during the year before the onset of symptoms. One individual 
reported up to 250 sexual partners in each of the three years prior to symptom 
onse,t. 

The possibility of AIDS transmission through rectal trauma (fisting or 
anal intercourse) is under study as a potential risk factor associated with 
reported cases among homosexual males._ 

To date, there have been no reported cases of AIDS among known female 
homosexuals. The frequency and type of sexual activity engaged in by 
homosexual female partners differs from male homosexual behavior. 

Haitians: Cases of AIDS have been identified among Haitian immigrants to the 
U.S. and also within the resident population in Haiti. The U.S. Public Health 
Service has epidemiologic investigators in Haiti attempting to determine 
whether AIDS cases there appear to represent the same syndrome, with similar 
"risk" factors to U.S. cases. 

Tuberculosis and other infectious diseases are more widespread and less 
well -controlled in Haiti than in the U.S. The hypothesis has been made that 
the immune system of some Haitians may be compromised or "overloaded" by 
previous exposure to infectious agents. 

Hemophiliacs : The fact that some hemophiliacs have developed AIDS has led to 
the concern that AIDS is transmitted through blood products. It is important 
to note that there are approximately 15.000 hemophiliacs in the U.S., yet only 
14 cases of AIDS have been identified among this reported "high risk group." 
Hemophiliacs receive frequent transfusions of Factor VIII, a blood component 
derived from several thousand donors for each transfusion. 

Blood clotting, like inflammation and wound healing, is part of the 
body's immune system response. Hemophiliacs, therefore, may be characterized 
as a group whose ininune system is compromised by an inherited defect. 

Preventive Measures 

Based upon all available data on AIDS, the following preventive measures 
appear prudent until the exact cause of the condition is identified. 

1. Illicit drug use should be avoided, particularly intravenous drug 

use; 

2. Sexually active homosexuals should be advised to limit the 

number of sexual partners and to avoid sexual contact with 
individuals v/liose past health history is not known. 



243 



DEPARTMENT OF HEALTH 
Submitted by: Dr. David Axel rod. Commissioner 

Agency Concerns ; 

1. Public misconceptions : The Centers for Disease Control has adopted 
a premise that AIDS is caused by an infectious agent. The public has 
interpreted this to mean that AIDS is a highly communicable disease. Anxiety 
levels have risen among health care workers, prison guards and inmates, 
funeral directors, laundry workers, members of "high risk" groups and the 
general public - primarily in New York City. Daily press reports of specific 
AIDS cases and highly speculative research findings published almost daily in 
scientific journals has built a body of belief in misinformation and 
inaccurate data disseminated by opportunistic researchers, uninformed medical 
professionals and government spokespersons. 

2. Inadequate case reporting & followup : AIDS is not yet a nationally 
•mandated reportable condition. Voluntary reporting by physicians and 

hospitals has been occurring, however, there are no established protocols for 
required case data or followup, resulting in a lack of completeness, 
consistency and comparability in case information. Information on AIDS 
incidence and case data provided back to all states monthly by the Centers for 
Disease Control has been sketchy, often inaccurate and significantly delayed. 
Inconsistent coding of cases to place of treatment or death, rather than to 
place of residence at the time of onset of the syndrome has complicated local 
epidemiologic followup and research activities. 

3. Civil rights concerns : The designation "high risk" has been 
assigned to specific sub-groups within the population, without accurate 
denominator counts of individuals within these groups as compared to reported 
numbers of AIDS cases. This labeling, combined with growing public panic 
about AIDS, can generate or reinforce prejudicial attitudes and lead to 
infringement of the human and civil rights of AIDS victims. With half of the 
AIDS cases nationwide, New York State should take a leadership role in 
pursuing epidemiologic descriptions of actual risk to sub-set populations and 
basic science research activities aimed at determining the characteristics of 
such populations which place them at risk. for immune disorders. 

Department Actions 

1. Public Information & Education : The Health Department has granted a 
total of $197,000 to the Gay Men's Health Crisis, Inc. in New York City for 
use in carrying out educational activities within the gay community. The 
organization has established a toll-free AIDS hotline and also provides 
personal counseling for victims and family members. 

A total of 50,000 brochures, prepared by the Health Department, have 
been distributed within the State prison system in an effort to clarify 
misinformation which has prompted anxiety among guards and inmates. Brochures 
currently are being printed for dissemination to the general public through 
local health departments, health care facilities and other State agency 
outlets. 



244 



2. Addressing health personnel concerns : In March, 1983 the Department 
disseminated informatiop on AIDS and general recommendations for patient care 
protocols to all hospitals in New York State. While we do not consider 
isolation of AIDS patients necessary, we have recommended that to allay 
employee concerns hospitals may wish to follow infection control protocols 
currently in place for patients with hepatitis B. Similar information has 
been provided in response to inquiries from laboratory personnel handling AIDS 
specimens and to funeral directors who expressed concerns about embalming the 
bodies of AIDS victims. 

3. C ase followup : The Department has worked cooperatively with CDC, 
loca*!, county and New York City health department staff on AIDS surveillance 
activities to obtain voluntary case information on New York AIDS patients. A 
separate surveillance system for prison cases has been established in 
conjunction with the Department of Corrections. 

4. Confidential Mandatory Reporting : At the request of the Department, 
the Public Health Council has taken emergency action to make reporting of AIDS 
cases by hospitals and physicians mandatory in New York State (effective June 
20, 1983) to ensure the confidentiality of such data under the Public Health 
Law. The department will develop case reporting forms and detailed 
questionnaires to obtain accurate, consistent case data for use in case 
followup and research activities. The case reports will be used to establish 
a confidential statewide registry of New York cases. 

5. Retrospective Prison Case Studies : The departments of Health and 
Corrections have worked cooperatively in evaluating AIDS cases among prison 
inmates. These epidemiological studies, published in three scientific 
articles, have demonstrated that virtually all AIDS cases among inmates in 
State prisons involve individuals with a prior history of IV drug abuse in the 
New York City area. There is no evidence that AIDS was contracted during 
incarceration or passed from one prisoner to- another. 

6. Laboratory Services : The Department's Center for Laboratories and 
Research (CL&R) provides general laboratory analysis for State and local 
government agencies and special laboratory services not otherwise available 
for hospitals and diagnosing physicians. Ongoing analyses related to AIDS 
diagnosis and treatment include: 

Serology for: hepatitis virus 
cytomegalic virus 
Barr-Epstein virus 
Toxoplasmosis parasite 
Various fungi and yeasts 
Syphilis (treponema pallidum antibody) 

Virus isolation of: Cytomegalic virus 

other common viruses 

Identification and characterization: atypical mycobacteria. 
Pathologic diagnosis: Pneumocystis infection. 



245 



Recommendations : 

1. Public information : The Governor's AIDS task force should mount a 
coordinated, multi-faceted informational campaign in an effort to convey 
accurate information to the general public, to dispel rumors and allay 
unwarranted public fears and to address the specific concerns of service 
workers who by nature of their occupations may come into proximity with AIDS 
victims. Planned activities include: 

a. Establishment of an AIDS hotline within the Health Department to 
answpr public inquiries. 

b. Initiation of periodic seminars for representatives of the news 
media, during which questions may be addressed to State agency personnel 
knowledgeable in various AIDS issues. It is hoped that this technique may 
prompt the press to look toward the State for accurate background information 
and balanced prospective on "breaking" AIDS stories. 

c. Distribution of informational materials on AIDS through all 
appropriate State agency outlets and mechanisms, 

d. Identification of all State personnel and other professional and 
service occupations (physicians, health care workers, funeral directors, EMTs, 
institutional employees, drug counselors, life guards, etc.) which may have 
concerns about AIDS. Development and dissemination of accurate informatiin to 
address the general and specific concerns of these groups. 

2. Research Activities : 

• a. Prospective Prison Innate Study : The department's Bureau of 
Communicable Disease Control (CDC) and Center for Laboratories and Research 
(CLSR) are preparing tandem grant applications to be submitted to the national 
Institute of Health to evaluate New York State Correctional Facility inmates 
who are previous IV drug-abusers and hence "at high risk for AIDS." 

The first stage of this research project involves a prospective 
cohert evaluation in which all entering inmates will fill out an extensive 
risk factor questionnaire on drug history and will receive a thorough physical 
exam and laboratory evaluation. The second phase proposes more extensive and 
sophisticated laboratory evaluation of blood and body fluids of those 
identified in the initial workup as potentially "high risk" for AIDS. 

b. Lupus/AIDS research : The recent finding of abnormalities or 
"inclusions" in the cells of patients with lupus erythematosis, some forms of 
cancer, and immunodeficiency diseases including AIDS will be investigated by 
the Department's Center for Laboratories and Research. A grant proposal to 
expand on-going NIH-supported research activities will incorporate a 
simultaneous study of inclusions in AIDS patients. 

c. Hemophilia : The department's recognized expertise in hemophilia 
research and hematology will be beneficial in further investigation of 
potential risk factors associated with reported AIDS cases among 
hemophiliacs. Our hematology laboratory is currently collaborating with the 



246 



Northeastern New York branch of the American Red Cross 1n an attempt to 
develop practical methods to improve the yield of factor VIII concentrates 
made by cryoprecipitation of single unit or small pool donations. This would 
provide an alternative for those mildly hemophiliac patients who do not 
require large pool factor VIII concentrate. Research also is in progress to 
improve the safety and minimize the risk of potential contamination through 
factor VIII therapy. Information materials addressing the fears and concerns 
of hemophiliacs are currently under development. 

d. Detection of Opportunistic Infections: AIDS victims most often die 
of the opportunistic infections or Kaposi's Sarcoma, These opportunistic 
infections are caused by an exotic group of microorganisms including bacteria, 
viruses, fungii and yeast. The Department's Center for Laboratories and 
Research currently functions as a statewide reference laboratory for 
identification of most of these organisms and, as such, provides assistance to 
State laboratories and health care facilities in the diagnosis of these 
agents. As an extension of these reference services, the Center will work 
toward: 

-- Development of a serological test for Pneumocystis carinii (PCP) 
which could provide early warnings of the impending illness and, if so, allow 
therapeutic intervention. At present the diagnosis of PCP is made by 
microscopic examination of bronchial washings from suspected patients. 

-- Development of a simplified test for toxoplasmosis which, along with 
PCP, is one of the more frequently detected opportunistic infections in AIDS 
victims. 

-- Enhancement of the laboratory's current capability for isolating and 
subgrouping of cytomegalovirus (CHV) virus to determine if a particular 
subgroup of CMV is specific to 'AIDS patients. 



247 



DEPAKIMENT OF CORRECTIONAL SERVICES 

Submitted by: Dr. Raymond Broaddus, Assistant Commissioner foL Health 
Services 

Background Data 

Itie first confirmed case of AIDS in the State prison system occurred in 
November, 1981. Since that time, 35 prison AIDS cases have been reported, 
with 18 deaths among inmates. Virtually all prison inmates with confirmed 
aids' had a previous history of intravenous drug use in the New York City 
area. All evidence indicates that they contracted AIDS prior to 
incarceration, since the condition ajpears to have a one to two year 
incubation period. 

Agency Concerns 

1. Care for inmate AIDS patients ; The correctional health service is 
basically designed to provide ambulatory care, with provisions for transfer of 
inmates requiring acute care to secure wards in outside hospitals. While this 
methodology has worked reasonably well in the past, it is being severely 
tested by the AIDS situation. Transferring a suspected AIDS case to an 
outside hospital for diagnosis and treatment is fairly routine. The problem 
develops when the outside facility discharges the inmate back to the 
institution. The inmate-patient whose opportunistic infection may have been 
arrested or stabilized is then placed in the receiving institution's infirmary 
which is geared to provide intermediate care and, when indicated, isolation. 
The above arrangement has become problematic given the limited isolation 
capability available within prison infirmaries. 

2. Protection of inmate AIDS patients ; While it is widely accepted 
that the primary mission of the Department of Corrections is to confine 
individuals committed by the courts so that society at large will be protected 
from them, there is also an obligation to protect inmates from other inmates 
who might be inclined to harm them. Given the existing public perception of 
AIDS as a "communicable disease" and the alarmingly high rate of anxiety among 
corrections' staff, (both uniform and non-uniform) and the inmate population, 
we have to consider AIDS patients as being victim prone. 

Recommenda t ions 

To provide the most comprehensive care to inmate-patients who have 
contracted AIDS, a hospital setting, preferably in the New York City area, is 
prerequisite. The bene'fits to be derived from this go beyond the medical and 
psychological wellbeing of the inmate-patients. Since all prison AIDS 
patients are from the greater New York City area, their care in the City would 
simplify visits from family members. 

Removing the AIDS inmate-patients from the prison system would greatly 
alleviate the fear and paranoia among staff and more importantly would greatly 
diminish the potential for a hostile and volatile reaction on the part of 
certain inmate factions. 



248 



The Department is prepared to negotiate reasonable financial 
arrangements with a contracting hospital subject to the approval of Division 
of Budget, and is committed to working out the security considerations for the 
proposed endeavor so that the interest of public safety will be appropriately 
served. It would be preferable to contract with New York City for the 
provision of security services for the secure hospital ward. In the event, 
however, that this proves to be impractical the Department is prepared to 
assume this responsibility. 



COMMISSION OF CORRECTION 

submitted by J. Kevin McNiff , Chairman 

Background 

In addition to the 35 reported cases of AIDS among State prison inmates, 
several cases have been diagnosed among prisoners awaiting sentencing at the 
Riker's Island facility. Fears and concerns are being expressed by 
correctional staff at all levels of the criminal justice system, including 
State and City facilities, county jails and local lockups. 

Recommendations i 

1. Education ; Developnent and continuation of educational programs on 
AIDS for inmates and employees is essential at all levels of the criminal 
justice system. 

2. Evaluation and Diagnosis ; Protocols are needed for use in the 
prison system regarding currently accepted procedures for evaluation and 
diagnostic workup of AIDS patients. The plan should be developed on a 
systemwide basis to ensure continuity and accuracy in evaluation, treatment 
and statistical analysis. 

3. Patient Care ; Definite plans should be developed for uniformity and 
continuity of care at the primary, secondary and tertiary levels, including 
the possible concentration/consolidation of services. 

4. Safeguards ; Plans should be developed for implementing safeguards 
to reduce risks for unaffected inmates and employees within the limits of 
current knowledge regarding AIDS. 

5. Program Services ; It is important to ensure that AIDS 
inmate-patients undergoing treatment are afforded reasonable access to program 
services as their conditions permit, particularly if consolidation of services 
is anticipated. 



249 



INSURANCE DEPARIMENT 

submitted by James P. Corcoran, Superintendent of Insurance 

Background 

Ihe Insurance Department has the responsibility of informing the public 
about insurance matters. As part of this responsibility the Department has 
directed its efforts to educate insurance consumers as to the scope and level 
of coverage available to them under health insurance contracts. 

issues 

A comprehensive health insurance policy delivered or issued for delivery 
in New York State will provide coverage for AIDS to the same extent that 
coverage is provided for other illnesses. Coverage for a specific disease or 
syndrome such as AIDS may not be excluded from the contract. If the health 
insurance contract covering an individual who has contracted AIDS provides 
benefits for preventive care and diagnostic and screening services, such 
coverage will be provided when the services are rendered as a result of AIDS. 
It should be noted, however, that many insurance policies do not provide 
coverage for preventive, diagnostic and screening services. Other policies, 
such as hospital indemnity insurance, are not comprehensive and would not. 
provide benefits for physicians' services rendered to a victim of AIDS. 

DIVTSION OF SUBSTANCE ABUSE SERVICES 

submitted by Julio A. Martinez, Director 

Background 

Intravenous (IV) users of illicit drugs account for the second largest 
group of AIDS victims; in New York City IV users account for 33 percent of 
identified AIDS cases. Current Center for Disease Control reporting methods 
count AIDS patients who are both homosexuals and IV drug users only as 
homosexuals. This significantly undorcounts the proportion of IV drug users, 
who may account for as many as 25 percent of AIDS victims nationally. 

There are 35,000 former IV drug users currently in methadone maintenance 
and drug-free treatment programs in New York State. An additional 250,000 
persons have used drugs intravenously within the past three years; about 
75,000 of this group ar'e current IV drug users. While heroin is the major 
abused drug, the recent sharp increase in cocaine use (which is continuing to 
climb) has contributed to a further growth of IV users. 



250 



The problem is most acute in New York City, where the majority of IV 
drug users reside and where there is a proliferation of "shooting galleries." 
Injection paraphernalia are rented at the galleries, where observations 
indicate that needles are almost never sterilized and are typically used by at 
least 25 persons before being discarded. There are a minimum of 1,000 such 
"galleries" in New York City. 

Reccanmendations 

' 1. Education : Education efforts should be instituted to alleviate 
undue concern among clients and program staff, to ensure reporting of 
suspected cases and delivery of prompt medical attention, and to reduce 
activities currently implicated in AIDS, such as IV drug use. All the 
publicity that AIDS has received in- the media has caused concern, similar to 
that of the prison guards, among program and laboratory staff personnel. The 
education efforts should be targeted for treatment program staff, for current 
and former IV dryg users, '^nd for the spouses and families of these 
individuals. - 

2. Monitoring ; Monitoring should t>e undertaken to assess the incidence 
of AIDS among former and present IV drug users, to ensure identification of 
all AIDS cases, to define those groups at risk, and to note any changes in 
risk groups. These efforts should include monitoring of former IV users now 
in methadone or drug-free treatment for AIDS symptoms and for knowledge of 
persons who have AIDS symptoms, and monitoring and epidemiological 
surveillance of active street IV drug users. 

3. Research ; Research is necessary to explore and define the etiology 
of AIDS, to study possible methods of transmission, and to ascertain possible 
effective treatment and preventive measures. Research efforts should include 
reexamination of pathology reports and tissue samples of suspected but 
unconfirmed IV user AIDS deaths; case control studies among IV drug users, 
"shooting gallery" IV drug users, and current IV AIDS cases, and natural 
history studies of active IV AIDS cases. 



OFFICE OF MENTAL HEALTH i . 

submitted by William Morris, Acting Commissioner 

Background 

As of May 31, 1983, among the forensic facilities and New York City 
psychiatric centers, one confirmed AIDS case was reported. This patient is 
being treated in a community hospital. There has also been a suspicion of 
AIDS in the death of two staff persons over the last year. 



251 



The Office of Mental Health (OMH) serves some 23,000 inpatients in 27 
adult and forensic psychiatric centers throughout the State. An additional 
110,000 patients are served through the outpatient system. Medical literature 
and the general, yet limited, knowledge available regarding AIDS indicates 
that two subsets of the OMH inpatient population may be at significant risk of 
contracting the disorder: the 1,325 forensic patients admitted each year to 
two OMH free-standing forensic faciities and four regional forensic units; and 
some 11,000 patients admitted annually to our five New York City psychiatric 
centers. 

If homosexuality and intravenous drug abuse are contributing factors in 
the development of AIDS, the OMH forensic population, which sometimes mirrors 
the correctional population and patients admitted to New York City psychiatric 
centers, where there is a history of high incidence of drug abuse on 
admission, are patient groups that may require special intervention. These 
assumptions can be more seriously considered when we recognize that: 

• 90% of all patients admitted to Central New York Psychiatric Center 
(CNYPC) , an acute care forensic facility, come directly from State 
correctional facilities where they are serving sentences. Upon discharge from 
CNYPC, patients usually return to the correctional system. 

• 98% of all patients admitted to Mid-Hudson Psychiatric Center (MHPC) 
come directly from county jails. This population includes patients found 
incompetent to stand trial, and those not responsible by reason of mental 
disease or defect. Upon discharge, depending on their legal status, these 
patients may be transferred to jails, prisons, or adult psychiatric centers. 

• The incidence of intravenous drug abuse among patients admitted to 
New York City Psychiatric Centers may be as high as 20%. 

Concerns 

1. Care for AIDS patients : OMH facilities will encounter difficulties 
in dealing with AIDS patients due to a limited ability to provide in-house 
treatment, and current difficulties OMH facilities encounter in acquiring 
services from community hospitals. The demand by some hospitals that OMH 
facilities send 24-hour staff supervision with patients admitted for care 
imposes a heavy burden on already diminished inpatient staff resources. 

2. Information ; There is a need for OMH facilities to receive current 
information and guidance on prevention and treatment of AIDS patients. 

Recommendations 

1. An interagency information/education process should be considered to 
reduce the fear and stigma attached to this syndrome. 



252 

2. CMH would like acditional clinical support and direction from the 
Department of Health in planning for the medical treatment needs of OMH 
patients, including laboratory diagnoses. 

3. Ihe possibility of developing an interagency uniform screening 
process, to be used at admission and discharge, should be considered. This 
system would assist in early detection and more accurate diagnosis of the 
syndrome. Blood transfusion history should be considered in the process. 

4. Statewide interagency guidelines should be developed defining 
adequate diagnosis and preventive measures for AIDS. A uniform reporting 
procedure, which generates consistent data, should be considered when 
developing such guidelines. 

5. Research being conducted at the State level or through CDC should _ 
also be targeted to potential high risk groups in the OMH inpatient population. 

6. OMH requests the assistance of the Department of Health in 
identifying community hospitals in each region for the prudent transfer, 
treatment and isolation of suspected or confirmed AIDS cases. 

Mr. Weiss. Mr. Rosen, in the course of your testimony you re- 
ferred to the fact that only patients with the CDC-defined AIDS 
have any chance at all of receiving assistance from the Govern- 
ment. Has there been any discussion with CDC or SSA that you 
know of about altering the definition of AIDS for the purpose of 
disability benefits? 

Mr. Rosen. Not that we know of. There has been no discussion 
with the CDC from ourselves and from any of our attorneys. But 
we are beginning to get more and more complaints from more and 
more people, people who have diseases like herpes oster, people 
who have programmable symptoms of AIDS and who really should 
not be working but are not able to get disability insurance. 

The CDC definition is a very limited definition of a certain 
number of diseases. 

Mr. Weiss. We have had testimony about the medical cost per 
patient, and how it overburdens not just the individuals, making 
them in many instances destitute, but also the institutions and the 
localities in which they receive the health care. 

The numbers we have received range from $60,000 to $100,000. 
Do you know how those figures were arrived at and whether they 
are accurate? 

Mr. Rosen. Those are not my figures, except I can tell you those 
figures are accurate. I am a social worker, Mr. Chairman, I have 
clients, I have about four clients now who have AIDS. One of my 
clients passed away 3 weeks ago. He was a man who made $40,000 
a year at the time of his death— after being in the hospital four 
times over the course of 2 years, his hospital bills were approxi- 
mately $100,000. I don't know what the numbers were testified 
about before would come to. But I can tell you they are certainly 
accurate based on reality. 

Mr. Weiss. Did that involve, if you know, any costs for the ex- 
perimental drugs such as interferon that were referred to earlier 
by Mr. Ferrara? 

Mr. Rosen. No, they were not, not in my cases. 



253 

Mr. Weiss. And finally, in the course of your testimony, I think 
on page 9, you refer, but only obliquely, to what you see as the po- 
tential for the disease, the epidemic, crossing the relatively narrow 
at-risk communities where they are now prevalent. 

Could you expand on that? I am not sure that I really understood 
what you were saying. 

Mr. Rosen. Well, most of the researchers — not everyone would 
agree with this — but many researchers would say that whatever 
this is, it seems to be transmitted sexually. And people in their life- 
time at different points in their lives have different types of sexual- 
ity. People are not static in their sexuality. People are not all het- 
erosexual, they are not all homosexual. Some people are bisexual. 
And throughout their lives they cross over. It is sort of a line that 
goes back and forth. Not everybody goes back and forth, but some 
people do, more people than you might want to hear about. 

If those people, and people are bisexual, and people are having 
sexual contacts with men and with women, it stands to reason that 
somewhere down the line, if we have an incubation period of from 
1 to 3 years here, the epidemic is going to spread out of it to the at- 
risk populations. 

Mr. Weiss. Thank you very much. 

Mr. Walker. 

Mr. Walker. I have no questions. 

Mr. Weiss. Mr. McCandless? 

Mr. McCandless. I have no questions. 

Mr. Weiss. I guess I have one area that I want to ask about. 

You referred to the Doctors Against AIDS, was it? 

Mr. Daire. Yes, Dallas Doctors Against AIDS. 

Mr. Weiss. Tell me about that. What is it about? 

Mr. Daire. First of all, none of these doctors are Dallas doctors. 
They all live in suburban areas of the Dallas region. Two are medi- 
cal directors, one is a dentist, and the others are doctors of philos- 
ophy. None of them have approached the subject of AIDS from a 
combating AIDS standpoint. In fact, attached to my testimony is an 
introduction of a bill by Representative Bill Severa which was very 
strongly supported by the Dallas Doctors Against AIDS, and it is 
very easy to see that it is not really Dallas Doctors Against AIDS, 
it is Dallas doctors against homosexuality and our lifestyle, nothing 
to do with AIDS, except the fact that they use AIDS as a weapon 
against us. 

Mr. Weiss. The attachment that you have will be entered into 
the record, without objection. 

Incidentally, I had forgotten to request earlier that the attach- 
ment Dr. Siegal had in his testimony also be entered into the 
record. 

Finally, Mr. Collins, how real is the concern that individuals 
have, in your estimation, about having their rights of privacy and 
confidentiality violated by the Government? 

We have heard references not only from you, but from other wit- 
nesses. Is that an abstract civil liberties concern, or is this a real 
concern of real people about what will happen to them individual- 
ly? 

Mr. Collins. I believe it is a real concern, as has been demon- 
strated several times today in other testimony. 



26-097 0—83 17 



254 

Moreover, we have heard the call for a central information bank 
for research purposes. And I would fully support that. But should 
such an information bank be set up, there does need to be some 
sort of control over that kind of information. We have seen a blos- 
soming of lists. In my limited amount of work that I have done, I 
have heard of lists in the blood centers, I have heard of lists in the 
CDC, I have heard of lists in the health departments, in State 
health departments, I have heard of the CDC sending a list to the 
State health departments, I have heard of mistakes by the CDC. 
And that is the real issue. 

The issue is human error as well. There is room for human error. 
The more you generate more lists, the much more room for human 
error. There needs to be some built-in protection, especially in light 
of the information that is being collected. 

Mr. Weiss. I want to thank all of you, indeed all of our witnesses 
today. Your testimony was just outstanding. We appreciate your 
giving us the benefit of your knowledge and expertise in this area. 

I know that we will make good use of the testimony in the course 
of the ongoing proceedings of this subcommittee. 

With your testimony, the hearings today are concluded, if there 
are no further questions by members of the panel. 

Tomorrow we will reconvene at 9:30 and we will hear from the 
administration and its representatives as well as from public 
health officers from various parts of the country. The time for the 
hearing tomorrow morning is 9:30. It will be in this room. 

The subcommittee now stands in recess until tomorrow morning. 

[Whereupon, at 4:10 p.m., the subcommittee adjourned, to recon- 
vene at 9:30 a.m., Wednesday, August 2, 1983.] 



FEDERAL RESPONSE TO AIDS 



TUESDAY, AUGUST 2, 1983 

House of Representatives, 
Intergovernmental Relations 
AND Human Resources Subcommittee 
OF THE Committee on Government Operations, 

Washington, D.C. 

The subcommittee met, pursuant to notice, at 9:41 a.m., in room 
2154, Rayburn House Office Building, Hon. Ted Weiss (chairman of 
the subcommittee) presiding. 

Present: Representatives Ted Weiss, John Conyers, Jr., Sander 
M. Levin, Buddy MacKay, Robert S. Walker, Alfred A. (Al) 
McCandless, and Larry E. Craig. 

Also present: Representative Barbara Boxer. 

Staff present: James R. Gottlieb, staff director; Susan Steinmetz, 
professional staff member; James F. Michie, chief investigator; 
Gwendolyn S. Black, secretary, and Hugh Coffman, minority pro- 
fessional staff, Committee on Government Operations. 

Mr. Weiss. The subcommittee will come to order. 

The purpose of this 2-day hearing is to explore a number of ques- 
tions relating to the outbreak of AIDS: 

Are adequate resources available for research, treatment, and 
prevention? 

How comprehensive are the research and surveillance activities? 

Has the Government's response been timely? 

What is the extent of coordination of the efforts to fight the epi- 
demic? 

What is the scope of public education and how effective is it? 

How accessible is health care for persons with AIDS? 

Is the confidentiality of those who suffer from AIDS being pro- 
tected? 

After listening to the witnesses who testified before the subcom- 
mittee yesterday, I have grave concerns about the Federal Govern- 
ment's response to the AIDS emergency. 

Three men who have AIDS courageously came forward and told 
their individual stories. The most disturbing aspect of their testi- 
mony was what they viewed as an agonizingly slow response by 
Federal health agencies. One person suffering from AIDS said, I 
came here today in the hope that my epitaph would not read 'Died 
of red tape'." 

A physician echoed that sentiment when he described the Feder- 
al effort as "bordering on the negligent." 

In the testimony of the 16 people we heard from yesterday — rep- 
resentatives of the affected communities, the medical and research 

(255) 



256 

communities, and volunteer service organizations — most frequently 
vocalized was the desperate need for additional funding. Money is 
required for greatly expanded epidemiology research and surveil- 
lance activities, for dissemination of accurate information about 
AIDS to both the medical community and the public, and for an 
array of support services such as outreach, early screening, ther- 
apy, legal assistance, home and hospice care, medical referrals, and 
crisis intervention. 

The witnesses also spoke about specific weaknesses in the Feder- 
al response to this public health emergency, weaknesses that de- 
serve the close scrutiny of this subcommittee: a lack of adequate 
financial resources for research into the cause, cure, and preven- 
tion of the disease; a lack of a comprehensive plan to coordinate 
research efforts across the country, and a lack of sensitivity toward 
the victims' need for confidentiality. 

To meet even the limited AIDS research budget it has allocated 
to date, it became clear yesterday that the Federal Government 
may be funneling funds away from crucial research activities in 
other health areas. The impression that the administration is trad- 
ing one public health program for another to satisfy politically im- 
posed budget constraints is inescapable. 

There was also evidence to suggest that the present epidemic of 
fear could have been avoided if an aggressive education and re- 
search campaign had been undertaken by Centers for Disease Con- 
trol. 

The many concerns raised by these witnesses, when combined 
with the refusal of the Department of Health and Human Services 
to provide this subcommittee with full access to its staff and 
records during the course of our oversight work, lead me to ques- 
tion very seriously whether the administration is indeed committed 
to mobilizing maximum Federal resources as swiftly as is humanly 
possible to conquer this dread disease. 

I look forward to the testimony of the officials representing HHS 
who will explain the Federal position in the second half of today's 
hearing. 

Because of the refusal of HHS, beginning with Secretary Heck- 
ler, to cooperate with this subcommittee in discharging our consti- 
tutional responsibilities, we are lacking the full documentation 
that would normally be available to us prior to questioning admin- 
istration officials. Consequently, I intend to schedule future hear- 
ings once we have obtained the appropriate documents. 

We will begin with the testimony of three public health profes- 
sionals. But before I call on them, let me take note of the fact that 
we do have a quorum present; that we again have Mrs. Boxer, who 
is a member of the full committee, with us. Without objection, she 
will continue to participate with the subcommittee in the course of 
today's hearings. 

And at this time let me call on our ranking minority member, 
Mr. Walker, for whatever opening remarks he may choose to make. 

Mr. Walker. Thank you, Mr. Chairman. 

I think that you have outlined with some specificity the concerns 
that were raised by the groups that appeared before us yesterday, 
and the individuals that appeared before us. Hopefully today's 
hearings will begin to put some of those concerns into perspective. 



257 

by giving us an opportunity to hear from the professionals in the 
Government who have been dealing with the problem and will give 
this subcommittee and the Nation a little better idea of what the 
response has been to the AIDS problem, and what our future 
course of action will be with regard to same. 

Thank you, Mr. Chairman. 

Mr. Weiss. Thank you, Mr. Walker. 

Is there any other member of the subcommittee who wishes to 
make an opening comment? 

Mrs. Boxer? 

Mrs. Boxer. Thank you, Mr. Chairman. Again I have an opportu- 
nity to thank you for allowing me to sit in with the subcommittee 
and tell you that I share the concern that you expressed yesterday, 
I share with you the concern that you expressed regarding this 
whole matter — concern about the inadequate level of funding for 
AIDS research, concerned about the slow pace of Federal action, 
concerned about the lack of an overall program emanating from 
the Federal Government, and I am very concerned about the 
stigma given to the Haitian community. I think Haitians have 
been stigmatized with what appears to be sloppy questioning and 
research. I am hopeful we can get to the bottom of that today. 

I am also looking forward to the testimony so that I can leave 
this room today feeling a little better about the state of this whole 
program. 

Thank you again for this opportunity. 

Mr. Weiss. Thank you very much, Mrs. Boxer. 

We have two panels this morning. Our schedule is to continue 
through the morning and the early afternoon. We will have to ad- 
journ when the House begins to consider legislation which this sub- 
committee is directly involved in, specifically the revenue sharing 
program. I anticipate that to be somewhere between 1 and 2 p.m., 
therefore, we will not be breaking for lunch. We may take a brief 
break just to allow all of us a chance to move about for a little bit. 

We will begin the testimony with three public health profession- 
als: Dr. David Sencer, commissioner of health, New York City, and 
Dr. Mer\-yn Silverman, director of health, San Francisco, will ex- 
plain how the local health departments in the two U.S. cities most 
hard hit by the epidemic are coping. We will also hear from Stan- 
ley Matek, immediate past president of the American Public 
Health Association, who will offer a broad public health perspec- 
tive. 

We will seek to learn the panel's views regarding the sufficiency 
of resources available to public health workers at the local level. 

As you gentlemen may know, this subcommittee is an investiga- 
tive and oversight committee and, therefore, swears in its wit- 
nesses. So if you would at this point rise, I will offer the oath of 
affirmation. 

Do you affirm or swear that you will tell the truth, the whole 
truth, and nothing but the truth? 

Let the record indicate that each witness nodded in the affirma- 
tive. 

Thank you very much. 

Let me welcome all three of you on behalf of the subcommittee. 
Dr. Sencer, if you will begin, we will continue from there. 



258 

STATEMENT OF DAVID J. SENCER, M.D., M.P.H., COMMISSIONER 
OF HEALTH, NEW YORK CITY, N.Y. 

Dr. Sencer. Thank you, Mr. Chairman, members of the commit- 
tee. 

I am Dr. David Sencer, commissioner of health in the city of New 
York. It is an honor to appear before you today to discuss the prob- 
lems that the city is facing because of the continuing occurrence of 
AIDS. It is a problem to the city; it is a problem to the people with 
AIDS, to the general public and the city government. 

First, to talk of the problems that the people with AIDS have. As 
of July 13, 1983, 877 individuals in New York City had been diag- 
nosed to have AIDS. At least 351 have died. Seventy percent were 
homosexual or bisexual males, and 22 percent were IV drug 
abusers. 

These data illustrate the extent of the problem. But what do 
these figures mean to the persons with AIDS? It means a long de- 
bilitating illness, usually culminating in death. It means loss of 
income. It means medical bills that can't be paid because insurance 
coverage runs out, because coverage is disallowed for many of the 
procedures that are necessary for the diagnosis and often experi- 
mental treatment or because they have no coverage. 

It means discriminatory actions by employers, landlords, and the 
general public. It means a constant threat to the privacy of the in- 
dividual with the disease — the risk of public knowledge of an indi- 
vidual's sexual orientation or illegal habit or residence status. 

I would like to add a word on behalf of the plight of the drug 
addict. They have no spokespersons. Yet, they represent at least 20 
percent of the diagnosed cases in New York City. It is a tragedy 
that the programs for drug abuse that could obviate the need for 
dirty needles are at this point in time being cut back when a new 
and deadly health problem is moving through this population. 

What are the problems for the general public? Fear of the un- 
known. How is this expressed? By suggestions of quarantine, by dis- 
criminatory actions, by irrational behavior. 

What are the problems for the city? Coping with close to 1,000 
persons in need of a completely different type of assistance, and a 
different approach to problems. At any one time, about 200 pa- 
tients are in the hospitals of New York City requiring complicated 
intensive care, expensive beyond comprehension. For each one of 
the persons in the hospital, there are two patients not in need of 
hospitalization, but in need of income maintenance, housing, home 
nursing care, a job. Because of the diagnosis, barriers are erected 
that would not be there for a patient with a disease such as Hodg- 
kin's Disease. 

What approaches have been taken by New York City to cope 
with these problems? First has been the need for an educated pro- 
fessional population, for without this base it is difficult to develop 
patient and public understanding. A monthly seminar is held for 
all health care professionals working with the patients, to facilitate 
early and informal interchange of information. To develop this in- 
formation, an intensive surveillance function is provided by the 
health department in conjunction with and support of the Centers 
for Disease Control. 



259 

The information from this surveillance is reported monthly, a 
copy of which is attached to this testimony. We are about to enter 
into a collaborative study to verify the reporting of cases in the 
surveillance. 

Second, there is a need for informed and understanding care 
givers. To this extent. Mayor Koch has established an interagency 
task force which meets biweekly, with representatives from all the 
city agencies involved with health, welfare, housing, and other 
social services. This group is augmented by representatives of the 
gay community and the Haitian community, as well as persons 
with AIDS and other concerned groups. The role of this group is to 
identify problems and seek ways in which they can be solved. 

Unfortunately, they cannot all be solved. For example, there is 
no way in which such a group can prevent loss of jobs because a 
patient has AIDS. But it can be established that this is a problem 
and ways sought to educate employers that AIDS patients are not a 
risk to others in the normal course of employment. This is being 
done, for example, by working with the New York City Business 
Group for Health, which reaches most of the major employers and 
the personnel departments of most corporations. 

Also, there is a need to keep the health care providers supplied 
with current accurate information so that patient care is not com- 
promised by ignorance. This is a subject of another monthly meet- 
ing of hospital administrators, labor unions, and physician groups. 

Third, there is a need to provide accurate and timely information 
to the public to prevent or modify concerns. This is done through 
pamphlets, hotlines, speaker's bureaus, press conferences. The 
mayor's last statement is attached. 

I could continue to describe the multitude of activities undertak- 
en in the city, but I prefer to focus on two issues: confidentiality 
and costs. 

There is great concern among the various risk groups that their 
privacy not be invaded, and that there be guarantees that when 
their names are given, there will be adequate protection of the 
names from groups who have no need to know. It is also in the in- 
terest of the individual patient and his health care giver to have 
available in a protected manner the names, so that patients can be 
contacted when necessary, if new tools of diagnosis and treatment 
become available. 

It is also in the interest of scientists engaged in finding cause, 
prevention and cure to be able to match records accurately. It is for 
these reasons that the city health department is not furnishing 
names to other agencies, but has developed a system to assure the 
safeguarding of names within the department and providing 
matching services to others in the legitimate medical research com- 
munity. 

Finally, a few words about costs. The cost of suffering and social 
ostracism cannot be measured. The costs of medical care for the 
syndrome are next to impossible to estimate. But let us make a few 
assumptions, erring on the conservative side. 

We estimate about 200 patients to be in hospitals in New York 
City on any given day. If we assume a cost of care to be $1,000 per 
day, this leads to an annual cost of $73 million. If this is not cata- 
strophic illness, I don't know what is. 



260 

I would hope that a lasting legacy to those who have suffered 
from AIDS might be a reconsideration of reimbursement policies 
with a goal of broader coverage for those illnesses that no individu- 
al or no single community can afford. 

I will be pleased to answer any questions. 

Mr. Weiss. Thank you very much. All the attachments men- 
tioned in the course of your statement will, without objection, be 
entered into the record. 

[The attachments follow:] 



261 

AIDS - SURVEILLANCE UPDATE* 
JULT 27, 1983 



SimVEILLANCE OFTICE: (212) 566-3630 
♦THESE DATA ARE OF A PRELIMINARY NATURE FROM AN ONGOING INVESTIGATION 



262 








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v\ ^^ 


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./: ■■'.-. :;:p:^.:J.J--i:_^r.... -■■■ 


-:.:.:X.17.~ !_. . . : - ■■ 


':l~:^:.- t 




- 


■::IL--i:^ <S ■ 


_5J '-^ZVl UJ.^ia^ 


■ :t—: '.'.'' ' : 


^5£ 


;. ■ : 







263 



NEW YORK CITY SUBVEILLAMCE - REPORTED CASES: June 16 - July 13, 1983 



MALES 


MEW CASES 


TOTAL CASES 


JTOTAL MALE 


CASES 


Kaposi's sarcoma (KS) 


38 


299 




(37) 




Pneuaocystis carlnil 












pneuiaooia (PCP) 


34 


374 




(46) 




wlchcut KS 












Other opportunistic 












Infections (001) without 












PCP or KS 


8 


133 




(17) 




TOTAL MALES: 


80 


806 








FEMALES NEW CASES 


TOTAL CASES 


t_ 


TOTAL FEMALE CASES 


KS 





4 




(6) 




PCP 


3 


44 




(62) 




001 


5 


23 




'.32) 




TOTAL FEMALES 


6 


71 








TOTAL CASES 


88 

: July 16, 


877 
1983 








CDC National Surveillance 




Total Dofflestlc Cases 


: 19C2 










Total Foreign Cases 


: 121 










TRENDS: 


Airs CASES 


Bi MONTH, NEW 


YORK 


CITY 




Month 


Number Diagnosed 






Number Reported 


1982 As 


of 7.13 


As of 6.: 


15 






July 


33 


(31) 






36 


August 


41 


(39) 






42 


SepteTBber 


45 


(45) 






38 


October 


51 


(51) 






30 


November 


44 


(43) 






47 


December 


39 


(37) 






39 


average no./ao. 


42 








37 


1983 












January 


62 


(61) 






55 


February 


43 


(42) 






68 


March 


51 


(47) 






65 


April 


^■^ 


(40) 






49 


May 


46 


(28) 






58 


June 


48 


(9) 






81 


July 


5 








20 


average no. /mo. 


50 








63 


(Jan- - June) 






















7-13-83 



264 



OTHET? OPPORTUNISTIC INTXCTIONS IN CASES WITHOUT KS OR PC7 





NEW 


YORK CITY 








No, 


m 


Candida (esophageal) 




41 


26 


Crptococcus (CNS) 




28 


18 


Toxoplasmosis (CNS) 




27 


16 


Cytomegalovirus 




17 


11 


Herpes simplex (lesion 


1 mo.) 


15 


10 


Atypical mycobacterlua 




11 


6 


Cryp'o sporldlum 




9 


6 


Mycobacterliim tuberculosis* 


5 


3 


Lymphoma (CNS) 




1 


1 


Progressive multifocal 








encephalopathy 




4 


3 



* These individuals subsequently had a second, more serious 
opportunistic infection diagnosed. 



AIDS CASE MORTALITY BY 


HALF YEAR OF DIAGNOSIS, NEW 


YORK CITY 






No. 
Diagnosed 


No. 

Dead 


(2) 


Cumulative 
No. Dead 


(2) 


1st half 
2nd half 


1978 
1978 



2 






(0) 
(0) 








(0) 
(0) 


1st half 
2nd half 


1979 
1979 


1 
5 


1 
4 


(100) 
(80) 




1 

5 


(33) 
(63) 


1st half 
2nd half 


1980 
1980 


9 

IS 


6 

14 


(67) 
(93) 




11 
25 


(65) 
(78) 


1st half 
2nd half 


1981 
1981 


41 
93 


30 
67 


(73) 
(72) 




55 

122 


(75) 
(75) 


1st half 
2nd half 


1982 
1982 


146 
253 


60 
95 


(41) 
(38) 




182 
277 


(58) 
(49) 


1st half 


1983 


301 


74 


(25) 




351 


(41) 



7-16-83 



265 







HALF YIAK 


OF 


SYMPTOM 


ONSET, NEW YORK CITY 












Number of cases 




Year 


of 1978 
of 1978 


H 


omo: 


sexual/bisexual IV User 


Haitian 





Other 


1st half 
2nd half 




8 











1st half 
2nd half 


of 1979 
of 1979 






4 
8 


1 

2 


1 



1 
1 


1st half 
2nd half 


of 1980 
of 1980 






15 
32 


1 
4 




1 




I 


1st half 
2nd half 


of 1981 
of 1981 






51 
86 


10 
17 


2 
2 



3 


1st half 
2nd half 


of 1982 
of 1982 






119 
143 


45 
64 


6 
9 


13 
7 


1st half 


of 1983 






92 


37 


10 


17 


AIDS CASES 


BY MUTUAiLY EXCLUSIVE 


RIS". GRCDP, NEW YORK 


aTY 




Risk Group 
Homosexual/ bisexual males 
IV drug user 






Number Z Total 


Cases 




611 (70) 






(no hi 
Hemophlll 
Other or 


story of 

ac 

unknown 


homosexuality) 




190 (22) 

(0) 

76 (3) 






Total cases: 








877 








AIDS CASES WITHOirr 


APPARENT RISK CP.OUP NEW YORK CITY 





Haitian (no history of hoaosexualicy 

or IV drug use) 31 

Unknown - died prior to interview 14 

Possible background Kaposi's sarcoma 2 

Possible transfusion associated 3 

Sextial partner of an "at risk" group 12 
Others: 

Interviewed - no risk factors established 9 

Open cases - under Investigation 5 



Total 



76 

7-13-83 



266 



AIDS CASES BY RESIDENCE, WEW YORK CITY 







Number 


(2? 




Manhattan 




421 


(48) 




Brooklyn 




117 


(13) 




Bronx 




91 


(10) 




Queens 




68 


(8) 




Richmond 




5 


(1) 




NYC-boro unknown 




107 


(12) 




New York State 




15 


(2) 




New Jersey 




24 


(2) 




Other 




25 


(3) 




Unknown 




4 


(1) 




AIDS CASES, 


AVERAGE AGE BY MUTUALLY EXLUSIVE 


RISK GROU? 






NEW YORX 


CITY 






Risk Group 


1980 } 


Year of Primary 


' Diagnosis 






1981 


1982 


1983 


Homosexual /bisexual 


n-19 


n-108 


n-275 


n-199 




38 


37.7 


37.3 


38.3 


IV user 


n-6 


n-17 


n-94 


n-"/0 




36.8 


34.8 


32.3 


34.5 


Haitian 


n-1 


n-4 


n-1 2 


13 




31 


33 


29.8 


32.2 


Other 




a-5 


n-16 


n-24 






39.4 


36.7 


35.2 



7-16-83 



267 



TEE CITY OF MEW YORK OFTICE OF THE MAYOR EOUARD I. KOCH 



tal: 566-5090 143-S3 

For Ralsase: 
Monday, June 6, 198 3 

STATSMENT 3Y MAYOR SDWAiO : . KQCK 
I HAVE JUST CONCLUDED A MEETING WITH A NUMBER OF MY 
COMMISSIONERS -.TiOSE DEPARTMENTS DE.\L WITH THE GENERAL PUBLIC 
.iU?D OCCASIONALLY WITH PATIENTS SUFFERING FROM ACQUIRED 
IMMUNE DEFICIENCY S'fNDROME (AIDS). AT THIS MEETING, DR. 
WILLIAM FOEGE, DIRECTOR OF THE UNITED STATES PUBLIC HEALTH 
SERVICE'S CENTER FOR DISEASE CONTROL IN ATLANTA, GEORGIA. 
AND DR. DAVID SSNCER, COMMISSIONER OF THE CITY'S DEPARTMENT 
OF HEALTH, REVIEWED FOR THE!-! AND FOR ME THE CLRRF.-JT 
SITUATION ON AIDS. 

THERE ARE A NIWBER OF RUMOi^S ASSOCIATED %..n AIDS. DR. 
FOEGE AilD DR. SENCER ARE ciE.RE TO HELP DISPEL SOME OF THE 
RL'MCRS, AND TO KEEP US ALL UP TO LATE ON THE FACTS. 

--iRE ARE SOME OF THOSE FACTS: 

— "^'2 C.iSES OF AIDS HAVE BEEN REPORTED IN NE;>' YORK CITY 
SINCE THE BEGINNING OF THE OUTBREAK IN 1973. 

— ALMOST ALL OF THE NEW YORK CITY CASES THAT CAN BE 
TRACED dAVE BEEN RELATED TO THE PREVIOUSLY DESCRIBED RISK 
GROUPS — MAINLY SEXUALLY ACTIVE HOMOSEXUAL MALES OR 
INTR.i.^'ENOUS DRUG ABUSERS. THESE ACCOUNT 50?. 94. PERCE!-^ ■IF 
THE REPORTED CASES. 

— ABOUT 3.5 PERCENT OF THE C.a.SES HAVE OCCURRED ?N 
RECENT ARRIVALS ?kOM HAITI. 

— ABOUT 2 PE.RC-.NT DIED BEFORE THEY COULL 3E 
INTERVIEWED. 



268 



THRSZ CASES MAY 3E RELATED TO BLOOD PRODUCTS, AND 

ONLY 4 AT THIS TIME CANNOT 32 ASSIGNED TO ONE OF THE RISK 
GROUPS. 

A SMALL GROUP OF VERY YOU^NG CHILDREN HAVE SOME OF THE 
CONDITIONS THAT ARE ASSOCIATED WITH AIDS, BUT THE 
PEDIATRICIANS OF THE CaMMUNITY ARE NOT SURE THAT THIS IS THE 
SAME DISEASE. 

THERE ARE ANY NUMBER CS RUMORS A30UT THE SPREAD OF AIDS. 
THESE INCLUDE ALLEGATIONS THAT THE DISEASE IS SPREAD THROUGH 
FOOD, THROUGH THE AIR, OR MERELY BY TOUCHING AN AIDS VICTIM. 
THESE RUMORS AR£ NOT TRUE. " 

AS FAR AS WE CAN TELL. AIDS IS SPREAD THROUGH SEXUAL 
CONTACT, THROUGH BLOOD PRODUCTS, OR THROUGH CONTAMINATED 
HYPODERMIC NEEDLES. 

KUMORS ABOUT AIDS HAVE PROMPTED IN MANY PEOPLE AN 
UNREASOWING AND 'JNREASONABLE FEAR OF CONTRAC^-'nG THIS 
DISEASE. THIS FEAR IS UNFOUNDED. 

LET ME DETAIL FOR YOU SOME OF THE THINGS THIS CITY IS 
DOING, BOTH FOR AIDS PATIENTS A:^D THEIR FAMILIES, AND TO 
COUNTERACT THESE RUMORS. 

— Vj-E have established an OFFICE OF GAY ."^nD LESBIAN 
HE.\LTH CONCERNS, AND HAVE CONTRACTED WITH TH.E GAY MSN'S 
HEALTH CRISIS FOR SOCIAL SERVICES .^^^D TRAINING IN HOSPITALS; 

— WE ARE CONVENING ALL LOCAL AIDS RESEARCHERS ON A 
MONTHLY BASIS, HAVE ESTABLISHED A REPORTING SYSTEM WITH CITY 
HOSPITALS TO KEEP TRACK '^=' THE SPREAD OF Td£ DISEASE, AND 
ARE WORKING WITH THE NEW YORK BLOOD CEirPER AND THE CENTERS 
FOR DISE.ASw CONTROL TO HELP FIND T.4E CAUSE OF AIDS,- 



269 



— WE AJtE DIAGNOSING OR TRSATING MORE THAN ONE-THIRD OF 
THE MEW YORK AIDS CASES IN rJEALTH AiTD HOSPITALS CORPORATION 
FACILITIES, AND ARE INVESTIGATING '-yHETHE:^ OR NOT A HEALTH 
FACILITY DESIGNED FOR AIDS PATIENTS AND THEIil F.VilLIES CAN 
BE ESTABLISHED IN A CITY -OWNED BUILDING IN GRESI^WICK 
VILLAGE r 

— WE AilS ENCOURAGING CONGRESS TO' APPROPRIATE MORE FUNDS 
FOR AIDS RESEARCH; 

— THE HUMAN RESOURCES AUMINISTRATIOS IS PREPARING TO 
ISSUE A REQUEST FOR PROPOSALS FOR ORGANIZATIONS THAT WISH, 
UNDER CONTRACT WITH THE CITY, TO PROVIDE HOME CARE FOR AIDS 
PATIENTS ; 

— A COMMITTEE DRAWN FROM CITY AGENCIES THAT DEAL WITH 
AIDS CASES NOW MEETS TWICE A MONTH, AND OFFICIALS FROM THE 
DSPARTMEiJT OF HEALTH ARE MEETING WITH UNION REPRESENTATIVES 
TO HELP ALLAY THE FEARS OF CITY WORKERS WHO DEAL WITH AIDS 
PATIENTS ; 

— WE WILL 3E SUPPLEMENTING OUR TELEPHONE HOTLXNES TO 
INCLUDE INFORMATION ON AIDS FOR THE GENERAL PUBLIC. 

WE ARE HERE TODAY TO HELP ALLAY PUBLIC FEARS ABOUT THIS 
IS EASE. 3UT I DO NOT WANT TO MAINTAIN THAT THERE WILL NOT 
3E MORE AIDS CASES IN THIS CITY. 

WE CAN, UNFORTUNATELY, EXPECT MORE OCCURRENCES IN A 
CITY OF THIS SIZE. A CASE MAY WELL DEVELOP IN A 
SCHOOLTEACHER, A SOCI.AL V.-ORKER OR A HEALTH CARE WORKER, 
SOME OF THESE INDIVIDUALS MAY HAVE A RISK FACTOR THAT THE"! 
DO MOT WANT 



?'/ 



26-097 0—83 18 



270 

MAOE PUBLIC. BUT XS LONG AS WE KEEP IN MIND HOW AIDS IS 
SPREAD, '/^ CAN BE SURE THAT THEIR CCCJPATION rAS iJOT PUT 
THEM OR OTHER PEOPLE AT RISK. 

I, AND TH£ MEMBERS OF THIS ADMINISTRATION, ARE PLEDGED 
TO KEEP YOU INFORMED ABOUT. THIS SITUATION. SCIENTISTS MAY 
MAKE IMPRECISE STATEMENTS, HEADLINE WRITERS MAY DRAW CiT 
THESE IMPRSCISIONS. 

BUT IF I, OR MEMBERS OF THIS ADMINISTRATION, THOUGHT 
THAT THE RISKS WERS DIFFERENT FROM THOSE I HAVE JUST 
DESCRIBED, I WOULD SAY SO. AND IF THE SITUATION CHANGES, WE 
WILL TELL YOU SO. 

Mr. Weiss. Dr. Silverman. 

STATEMENT OF MERVYN F. SILVERMAN, M.D., M.P.H., DIRECTOR 
OF HEALTH, SAN FRANCISCO, CALIF. 

Dr. Silverman. I am pleased to have the opportunity to speak 
before the subcommittee both as the director of health of San Fran- 
cisco, and as the vice president of the U.S. Conference of Local 
Health Officers, on what is considered to be the number one public 
health problem facing this country today. 

Although the total numbers of those afflicted do not approach 
other health problems such as heart disease, cancer and stroke, the 
mortality rate of AIDS certainly places it at the top of the list. I 
am sure that you are aware that the care of these patients has 
become a local public responsibility. San Francisco now has the 
second highest number of AIDS cases in the country — 239 as of 
July 18, with 74 deaths. For a city and county of 700,000 popula- 
tion, this makes us No. 1 on a per capita basis. 

To deal with this problem, it is obvious that San Francisco did 
not earn its title "The City That Knows How" without good reason. 
Several years ago, before AIDS had become a household word, the 
mayor and the department of health were already at work trying 
to create a continuum of services to meet the needs not only of the 
victims of this horrible disease, but their partners, friends, families 
and the public at large. 

The involvement of the department has followed four distinct 
program themes: epidemiology, clinical diagnosis and treatment, 
education and training, and coordination of activities. None of 
these program activities could have been possible without the local 
provision of funds to support them. 

Beginning with epidemiology, the department in July of 1981 es- 
tablished a reporting system and case registry for AIDS cases diag- 
nosed in San Francisco and the surrounding bay area counties. 
This was done in collaboration with CDC and the California State 
Department of Health Services. We then established liaison with 



271 

local health and medical agencies involved with AIDS epidemiol- 
ogy, treatment, and research. This included such things as confer- 
ring with local treatment facilities about therapy and research ef- 
forts. 

A third activity involved investigating and interviewing AIDS 
cases. We worked with the University of California in San Francis- 
co and our San Francisco General Hospital in their cross-sectional 
studies, investigating blood transfusion-associated cases and the 
DCD hepatitis cohort study of AIDS cases. Six months ago, I re- 
quested that all cases of AIDS seen by private physicians be report- 
ed to my health department. It is now a reportable illness in Cali- 
fornia. 

The second major program theme is clinical diagnosis and treat- 
ment. In October 1982, a multidisciplinary AIDS clinic was begun 
at San Francisco General Hospital. This clinic provides AIDS 
screening, diagnosis, treatment and followup as well as education 
and counseling and, because of the increased patient load, it is now 
operating on an expanded schedule. Two of the city's district 
health centers and the city's clinic for sexually transmitted dis- 
eases also provide AIDS screening to patients in order to relieve 
some of the burden on our hospital. 

About a week ago, a medical special care in-patient unit opened 
at San Francisco General Hospital. This is an 11-bed unit, primar- 
ily for AIDS patients. I want to stress it is for the protection of the 
AIDS patients — not for the purpose of isolating them. We feel they 
have more to risk from us than we have from them. And we also 
want to try and provide a complete care, not only the medical as- 
pects but the psychiatric aspects, the social aspects, and provide a 
total treatment program so that all their needs are met. 

An important aspect of AIDS therapy is the psychosocial compo- 
nent. Certain city-funded nonprofit community agencies, as well as 
our community mental health centers, and staff at San Francisco 
General Hospital provide professional and lay counseling to pa- 
tients, their loved ones and to the worried, well — those individuals 
at risk of contracting AIDS who are extremely anxious about it. 

The third program area is education and training, which are in- 
tegral parts of all of our AIDS activities. The focal points for these 
activities have been the department's Lesbian/Gay Coordinating 
Committee, staff from the University of California and San Fran- 
cisco General Hospital, and two city-funded nonprofit agencies. 
Since May of 1982, this committee has sponsored over 30 training 
sessions for a variety of groups, including health workers, police 
personnel, social service employees, the general public and mem- 
bers of the gay community. 

Individuals within and outside the department have participated 
in these sessions and have appeared on local radio and television. 
Information has also been developed and distributed about AIDS to 
the professional and lay community. In May, we sponsored a 
citywide symposium on AIDS. Over 500 people attended a Sunday 
morning meeting to learn more about this public health problem. 
This month, a major symposium is planned for health care work- 
ers. 

The last program area deals with coordination of activities. In 
July 1982, a community coordinating committee was established 



272 

with the purpose of bringing together people representing all as- 
pects of the epidemic. This included clinicians, researchers, health 
educators, patients, gay activists, and many others. Information is 
shared, gaps identified in the system, and recommendations are 
made to the city and the department. This group has developed a 
community aids resource directory and has made recommendations 
for new services. 

In order to keep abreast of current treatment and research, I 
have appointed a medical advisory committee, composed of clini- 
cians and researchers, who meet with me on a regular basis to dis- 
cuss and recommend policy guidelines relative to AIDS. This com- 
mittee has been instrumental in reviewing the infection control 
guidelines prepared by the university and my office. 

After many weeks of work, through consultation with CDC and 
representatives of the academic, research and general medical com- 
munity, we have put together what we have purposely called guide- 
lines, because each medical facility may have specific situations 
which warrant greater or lesser emphasis on the various aspects 
contained within this document. 

In June, I met with representatives of the many different busi- 
nesses serving the gay male population in San Francisco. As a 
result of that meeting, we have complete support for the posting of 
signs and distribution of flyers which indicate the measures that 
can be taken to reduce the spread of the disease. 

With the exception of a portion of our epidemiologic activities, 
the city has financed all of the AIDS services I have described. Ad- 
ditionally, the city has funded nonprofit community agencies to ad- 
dress specific components of the AIDS problem. For example, the 
AIDS and Kaposi's Sarcoma Foundation was funded to establish an 
educational clearinghouse and to produce materials focusing on the 
at-risk population. The Shanti project, which is an agency serving 
the emotional needs of terminally ill patients, their loved ones, and 
friends, was funded to provide counseling and to set up residences 
for displaced AIDS patients. 

Last month, the mayor and the board of supervisors approved 
spending an additional $2 million from within our budget, which 
doubles the money presently being spent annually by the Depart- 
ment of Health for AIDS services. The rapidly increasing incidence 
of AIDS, along with the secondary problems of anxiety, misinfor- 
mation, displacement of patients and difficulties in treatment, \yas 
the motivation behind this authorization — this money now totaling 
$4 million, which will increase the services in the areas that I have 
mentioned. 

I have also hired an AIDS coordinator to try and coordinate all 
of the activities that are taking place, so that we have a better 
handle on the problem, both the social, psychological, and medical 
issues. 

Obviously, San Francisco and other impacted communities 
cannot continue to meet these needs without Federal support. Fed- 
eral funds are needed to supplement these costs as well as the re- 
search component. Education, counseling, screening, outpatient and 
inpatient and hospice services as well as residential facilities are 
costly at a time when local governments are least able to meet in- 
creased demands. One form of relief would be the immediate avail- 



273 

ability of medicare coverage for AIDS patients rather than the 24- 
month waiting period. Also, SSI should be granted as presumptive 
eligibility on diagnosis rather than the 60- to 90-day wait that pres- 
ently exists. 

AIDS patients who apply for SSI regularly must wait several 
weeks or months for certification. This is because rules require the 
submission of medical records to a separate agency in another city. 
This is not the case in 1 1 specific categories of inpatients where the 
Social Security district office may make a determination of pre- 
sumptive disability on the spot. A diagnosis of AIDS should be 
added to this list to facilitate the immediate granting of SSI. The 
relevant social security regulations are located in title XX of the 
code, Federal regulation 416.931 to 416.934. 

An alternative approach that may be quicker would be to get 
social security to interpret rather than change social security regu- 
lation 416.933 to include AIDS diagnosis. 416.933 states that, and I 
quote: 

We may make a finding of presumptive disability or presumptive blindness if the 
evidence available at the time of the presumptive disability or presumptive blind- 
ness decision reflects a high degree of probability that you are disabled or blind. 

It is interesting to note that no disease has ever been eradicated 
through treatment — only through prevention. That is why it is im- 
perative to have sufficient funding to establish the cause, provide 
the necessary treatment, and, most importantly, put into effect the 
preventive measures which will eliminate AIDS from its dubious 
distinction as the No. 1 public health problem facing America 
today. 

Thomas Adams summed it up very well over 300 years ago when 
he said: "Prevention is so much better than healing because it 
saves the labor of being sick." 

Thank you. 

Mr. Weiss. Thank you very much. Dr. Silverman. 

Mr. Matek. 

STATEMENT OF STANLEY J. MATEK, IMMEDIATE PAST 
PRESIDENT, AMERICAN PUBLIC HEALTH ASSOCIATION 

Mr. Matek. Thank you, Mr. Chairman, members of the commit- 
tee. 

You have our written statement, so I will try to just highlight 
the key points instead of reading it. 

Mr. Weiss. Without objection, your entire statement will be en- 
tered into the record. 

Mr. Matek. Thank you, Mr. Chairman. 

In the light of your opening comments about your interest in 
hearing from the administration, I would like to emphasize one 
point we take very seriously: Dr. Brandt is a professional seriously 
committed to these issues. But we must recognize that he takes his 
orders from above. We don't think that the Centers for Disease 
Control or the National Institutes of Health or Dr. Brandt ought to 
be the focus of criticism when, in fact, the decisions on what will or 
will not be done in the allocation of moneys and in service and re- 
search programs are being made by the Office of Management and 
Budget and by the White House. We wish to emphasize that in 



274 

looking to ultimate responsibility and to decisionmaking power, we 
must all look there. . 

APHA recognizes that although CDC and NIH are domg as much 
as they can, they are not doing enough. They are not doing enough 
because they don't have the resources, because they are under- 
staffed. We look to Congress to remedy that situation. 

We would like to see leadership from the White House. It has not 
yet been forthcoming. 

The priority now, as we see it, in this Nation relative to AIDS is 
for the prompt development of a comprehensive research surveil- 
lance and monitoring program. If we don't have that — and if we 
don't have it quickly— any money, any time or any talent put into 
the AIDS effort is going to be in large part wasted, because without 
a comprehensive plan, we are merely shooting in the dark with sci- 
entific scatter guns. 

We, therefore, ask — and we ask urgently — that within the next 
45 days Assistant Secretary Brandt convene a meeting of national 
experts in epidemiology, immunology, medical research, and other 
appropriate disciplines for the purpose of developing an AIDS re- 
search master plan, from which will follow a realistic budget and a 
priority list. 

We then ask that that research plan be used to guide AIDS grant 
awards in the National Institutes of Health, and that the adminis- 
tration refrain from counting among its AIDS activities those pre- 
viously funded projects which are only tangentially related to AIDS 
and which are not part of that master plan. We need, first of all, to 
have a realistic fix on what is or is not being done in a focused and 
organized way. We don't have that yet. 

Then we think that Dr. Brandt needs to appoint a standing 
expert advisory panel which includes people from outside NIH and 
the Department, as well as from inside. That is not just a sunshine 
provision; it is intended to give the programing, the planning, and 
the analysis an enriched dimension. 

We also respectfully ask that Dr. Brandt assign for prompt im- 
plementation the interprofessional AIDS update report which has 
been talked about now for several months, but which we have not yet 
seen. 

And, finally, we would like to make some brief points relative to 
programing. First, we recognize that CDC cannot do everything by 
itself. The job is getting too big and the problems are too spread 
out. Adequate surveillance and monitoring cannot be done only 
from the center. We would therefore like to see the efforts relative 
to AIDS surveillance, monitoring, and applied research decentral- 
ized, at least to the point that those cities where the major AIDS 
case clusters occur become capable of doing surveillance and moni- 
toring themselves. And we recognize that it is going to take some 
Federal money. We would like Dr. Brandt to order such a decen- 
tralization and to plan for its implementation as soon as possible. 

Second, we believe it is necessary for AIDS to be declared a re- 
portable disease nationwide. However, we recognize the problems 
that occur relative to the distorting of incidence data when report- 
ing programs are instituted; therefore, we ask that a definitive 
plan for protecting the confidentiality of the caseload and the pri- 
vacy of the patients be created. 



275 

We understand that that plan is now being developed in conjunc- 
tion with Dr. Sencer in New York City, and CDC. We would like to 
add one item to that proposal, namely that Zip codes be used in the 
identifying information, because without Zip codes it will not be as 
easy to do proper applied research or good treatment planning. 

Third, we would like to urge that funding be provided for treat- 
ment and prevention — as we understand, Mr. Chairman, it is in 
legislation you are introducing. But we would like to note that be- 
cause our hospital system is now such a high-cost system, money 
for treatment and prevention usually gets used exclusively for 
treatment. Our hospital system tends to consume whatever is avail- 
able because we have a high technology orientation to treatment. 

If we are serious about having money for prevention, we are 
going to have to segregate it. And we call that to your attention so 
it can be done — if not in legislation, then in regulation. 

As Dr. Silverman pointed out, prevention is what really works. 
Prevention is what protects the population. But unless we budget 
specifically, we tend to lose that money. 

We would plead also with the White House, with 0MB, with Sec- 
retary Heckler, and everyone involved in dealing with AIDS to ac- 
knowledge the epidemiological urgency of this problem. We know 
there are problems. We know NIH moves slowly. We recognize that 
CDC does not have a practice of decentralized approach to prob- 
lems. We recognize that Congress itself likes to fund things categor- 
ically. And we know that these are all system problems. But the 
AIDS issue should not be the issue on which we seek to leverage 
reform of our systems — not now; not with this problem. 

Finally, we urge that instead of belaboring past failures, we all 
look to the next steps toward solution. It doesn't so much matter 
what our mistakes were yesterday as what our solutions are today, 
and what our actions will be tomorrow. 

We are grateful to Congress because that is whence the leader- 
ship for change has come relative to AIDS. We urgently hope that 
you will continue that initiative. 

The American Public Health Association volunteers to do any- 
thing you or the administration or CDC or NIH might think that 
we can do to be of help. 

We thank you for this opportunity to talk with you. 

[The prepared statement of Mr. Matek follows:] 



276 



Testimony Of STANLEY J. MATEK, 

Immediate Past President, 

AMERICAN PUBLIC HEALTH ASSOCIATION 

before the 

Intergovernmental Relations and Human Resources Subcommittee 

of the 
Committee on Governmental Operations 



Mr. Chairman, Honorable Members, Ladies and Gentlemen: 

I am here this morning on behalf of the American Public Health Association, 
the world's largest association of public health professionals. We are 
particularly grateful to have this opportunity to comment on current efforts 
to deal with Acquired Immune Deficiency Syndrome, because the morphology of 
this illness qualifies it beyond any question as the most serious public 
health disease issue in decades. On the basis of incubation period alone, 
AIDS is an epidemiological nightmare, the horrors of v;hich are only beginning 
to unfold. The extent of exposure, the scope of susceptibility, and the real 
rate of incidence are all unknown. The agent is only hypothesized, and the 
mode of transmission is but vaguely suspected. There is no known form of 
treatment, the disease career is protracted, and the associated expenses are 
phenomenal. The situation demands the immediate use of the full 
armamentarium of public health techniques. Unfortunately, our response 
thus far fails to measure up to that demand. 

It cannot accurately be said that the Public Health Service or the 
National Institutes of Health have been derelict. They have done what they 
could with the resources available to them, going even so far at CDC as to 
siphon funds quietly away from other necessary programs. But it must be 
acknowledged that AIDS-related efforts in all quarters of our system thus 
far have been ad hoc , largely expedient, and gravely incomplete. 

These inadequacies stem neither from a lack of ability nor a lack of good 
will within our pioblic systems, but clearly and almost completely from a lack 
of resources. It has been disappointing to hear recent charges of unresponsiveness 
on the part of CDC and NIH relative to their AIDS-related activities. But 
such appearances can be understood easily enough by reference to the fact that 
these agencies are underfunded, understaffed and overworked. It is clear, 



277 



moreover, that the Administration's marching order to these program directors 
is unequivocal: "Don't ask for any money; make us look as good as you can 
with what you've got." 

It is obvious that additional funds must be made available; AIDS cannot 
be addressed on the basis of existing budgets. The 50,000 members of APHA 
are unanimously grateful to you, Mr. Chairman, to Congressman Waxman and 
to the others in Congress, on your staffs and elsewhere who have contributed 
thus far to the procurement of additional monies for AIDS research and treat- 
ment. We ask fervently for persistence in these efforts. 

But we must caution that even if additional funds are made available, 
that will not in itself enable us to cope competently with the AIDS problem. 
Thus far our quests both for cause and cure represent little more than mere 
shooting in the dark with scientific scatter guns. The application of the 
public health model of practice to this situation is long past due. 

The APHA Executive Board at its July meeting reviewed the AIDS situation 
and concluded that the nation's single most urgent current need is the prompt 
development of a comprehensive AIDS research, surveillance and monitoring 
plan. Without such a plan we will unwittingly waste much of whatever time, 
talent and money are applied to the AIDS problem. _ 

We, therefore, ask that within the next forty-five days Assistant 
Secretary Brandt convene a meeting of national experts in epidemiology, . 
immunology, medical research and other appropriate disciplines for the purpose 
of developing an AIDS research master plan, a realistic budget, and a 
priority list. 

We ask that this research plan be used to guide AIDS grant awards by NIH, 
and that the Administration refrain from including in its AIDS activity 
reports any projects funded for other purposes, which are only tangentially 
related to AIDS, and which are not part of the master plan. 

Then, because priorities will need to be changed as new information 
becomes available, we ask that Dr. Brandt designate a standing expert 
advisory panel , which includes members from outside NIH and the Department. 

We respectfully urge also that Dr. Brandt assign for prompt implementation 
the interprofessional "AIDS update" report which has been talked about now 
for several months. 

And finally, because any master plan must address and in certain senses 
must rest upon various policies, procedures and interagency agreements, we 
would like to make the following brief points: 

First, the achievement of adequate surveillance and monitoring will 
necessarily require that these activities be decentralized by the Center for 
Disease Control, at least to the extent of expanding local health department 
I 



278 



capacities in those jurisdictions where the major AIDS case clusters occur. 
At present these would include at a minimum the cities of New York, 
San Francisco, Los Angeles, Miami, Philadelphia, Boston and Newark. We ask 
that Dr. Brandt direct such decentralization, and convene a meeting of 
these local health officers and CDC task force leaders to develop 
implementation policies. 

Second, we believe it is essential that AIDS be declared a reportable 
condition nationwide. But we recognize that a particular problem with 
confidentiality is involved, and we note the well-known distorting influence 
which this factor can have on incidence statistics. The recent downturn in 
the number of new cases identified in New York, for example, might well be 
an artifact of that state's new reporting requirement cccibined with 
well-founded concerns about our system's ability to assure adequate privacy. 
We understand that New York City Health Commissioner Senser and the 
National Gay Task Force have devised a workable plan for dealing with the 
privacy issue, and we commend them. We would, however, like to add one 
important item to their proposal: We urge that any reporting system include 
the zip code of residence, because that information will have significant 
utility in applied research, and expecially in efforts at prevention and 
service planning. 

Third, we wish to note that although it may presently be necessary to 
combine under one legislative provision new funds for AIDS treatment and 
prevention, we have long and conclusive experience which demonstrates that 
treatment urgencies in our high cost hospital system will consume whatever 
funds become available. If, therefore, we intend to have funds for 
prevention, it will be necessary to assign them specifically by percentage 
or dollar amount, either in legislation or regulation. To neglect this point 
will be to lose once again any viable efforts at meaningful prevention. 
Fourth, we plead with the White House, OMB, Secretary Heckler, the 
National Institutes of Health, and all others involved in the question of 
AIDS funding decisions to recognize the epidemiological urgency of this 
situation, and to resist any temptation to draw inappropriately rigid 
policy lines, or to use the AIDS crisis as leverage for the reform of flaws 
in our current systems. The imperfections in process at NIH, the tendency 
towards solo performance at CDC, and the limitations of the categorial 
funding approach long favored by Congress are all well known problems. 
They are worthy of attention and remedy. But not now, not using the AIDS 
crisis as the lever. Efforts at system reform must not be made on the backs 
of AIDS victims and the hundred of thousands of our citizens now at risk. 

Finally, Mr. Chairman, we at APHA hope that your Committee, Mr. Waxman's 
Committee, and the Congress of the United States will continue to press forward 
on this issue, giving leadership where the White House thus far has not. We 
urge the Department and Dr. Brandt to take the necessary next steps. And we 
sincerely offer APHA's assistance and participation wherever the Department, 
the Congress or the Administration might desire it. 

On behalf of all the membership of APHA, I thank you for this 
opportunity. 



279 

Mr. Weiss. Thank you very much. 

Before we start our questioning, may I indicate again that we 
will be operating under a 5-minute rule. I have only one question. 

I thought that the testimony was very clear and precise. I am im- 
pressed by the efforts which your local organizations and the 
American Public Health Association have undertaken, as well as 
by the responsibilities which have been assumed by other localities. 

I am also impressed by the cooperation and coordination that ap- 
parently exists between the departments of health in your cities, 
and especially the gay community, which is the community most 
affected in this situation. 

: We have had discussions over the course of not only these past 2 
days but since we have taken note of the problem in Congress as to 
the budgetary problems involved. Dr. Sencer, you have indicated in 
your testimony that if you assume that only 200 patients are hospi- 
talized per day in New York City at a $1,000 per day cost, that you 
are talking about a bill of around $73 million a year. 

Could each of you try to give us what you consider to be your 
overall best guess or judgment as to what kind of moneys are 
needed for research, treatment, and the various corollary educa- 
tional and other services that you each have spoken about? What 
kind of money are we talking about annually or over the course of 
the next 3 years? 

Dr. Sencer? 

Dr. Sencer. Speaking only for the city of New York, it is our es- 
timate that in the health department alone we are expending on — 
(this does not get into the matter of diagnosis or treatment) — 
purely the public health aspect, surveillance, public education — we 
are spending about $1 million at the present time. And $125,000 of 
that is in the form of a cooperative agreement from CDC for the 
type of decentralized surveillance that Mr. Matek was talking 
about. The rest is out of direct city funds — we had a $250,000 new 
appropriation — we are using other existing funds. 

Other departments such as the welfare department, are spending 
an untold amount. And the Hospital Corporation is part of that $73 
million. 

I would estimate that in New York City, the cost of treatment of 
AIDS plus the prevention work, the surveillance work, the commu- 
nity support is going to come close to $100 million. And most of 
that is going into the treatment aspect of it. 

Mr. Weiss. Do you have any estimate or any basis for making 
any estimate as to what you think ought to be spent at the nation- 
al level, both for research as well as the other activities you spoke 
about? 

Dr. Sencer. I would not want to speak to the amount of money 
that should be spent for treatment. Let me just speak to the re- 
search. I think research is driven by the individuals who are capa- 
ble of doing the research. Rather than approach it from a finite 
dollar, I think that in a situation like this there needs to be a cer- 
tain open-endedness of the appropriation system and the NIH re- 
search grant administration, so that as fundable good research be- 
comes available, it can be funded in a situation such as this. 

I just hate to say $15 million, $20 million, because it depends 
really upon the ideas and upon the capability of the investigators 



280 

in the field rather than Congress or the administration setting a 
dollar figure to shoot at. This is when you end up with other things 
being charged against that particular budget. 

Mr. Weiss. Thank you. 

Dr. Silverman? 

Dr. Silverman. Yes. 

As I mentioned, we are spending over $4 million a year in San 
Francisco. And just a rough estimate for most of the prevention ac- 
tivities, the counseling activities, the educational activities, all of 
these kinds of things, in looking at it, I would suggest — and this 
would also help for the outpatient activities and some of the inpa- 
tient activities — about $25,000 per case. Obviously, that averages 
out when someone is in the hospital that it is a lot more. 

I think for treatment, rather than getting into a specific number, 
if we can change the medicare policies so that the cities are not 
burdened with this, and if we can change the SSI policies, so that 
would take some of the burden off, that would reduce the local ex- 
penditure. 

With regard to research, it is a hard one, but I also know that 
when a great deal of money is put into research and it is carefully 
distributed, results do appear. And a lot of the research that we 
are talking about that I want to see besides the basic research is 
epidemiologic research, and that costs a lot of money because there 
is a lot of investigation, a lot of interview. And I think the figure of 
about $50 million for 1984 is a pretty good ball park number. 

Now, it is hard to get much more specific than that. But I think 
that is a number that we feel would hopefully be adequate. 

Mr. Weiss. Mr. Matek. 

Mr. Matek. Mr. Chairman, I would comment that Dr. Silver- 
man's figure of $50 million represents not a final, total budget but 
a next step. It might be an annual allocation to get things rolling. 

Bluntly speaking, there is no responsible answer to your question 
now. There could be within about 90 days if Dr. Brandt would con- 
vene the panel we recommended very promptly. I would propose 
that Dr. Brandt be given 100 days to give you a responsible answer 
to your question on condition that the answer not be censored by 
0MB first. 

Mr. Weiss. Thank you very much. 

Mr. Walker. 

Mr. Walker. Thank you, Mr. Chairman. 

Dr. Sencer, I have been reviewing some of the attachments that 
you sent along with your statement with regard to the number of 
cases and so on. It interests me that in 1983 we have seen a signifi- 
cant drop in the number of cases, where you show the onset of 
symptoms, particularly in the second quarter of 1983. 

Is there any explanation you can give us? 

Dr. Sencer. Yes, there is an explanation. This is the date of 
onset of symptoms, and many of the cases are not reported until 
they have been ill for a period of time because sometimes the onset 
of symptoms is not pathognomonic of AIDS. 

If you look at the next page, the bottom of the page, "Trends," 
you will see we are having an average of 50 cases reported a month 
in New York City. It is up a little over last year, when we were 



281 

having 42 cases a month. This year, we are seeing 50 cases a 
month. So I don't think this is an artifact of the reporting process. 

Mr. Walker. That helps clarify. Thank you. 

The other thing that I noticed is that you have recently stated 
that the Haitians should be removed from the list of major AIDS 
risk groups. Certainly, in some of the testimony we had yesterday, 
it would seem to suggest that, too. But in your statistical list, the 
AIDS cases without apparent risk group that you gave us does indi- 
cate that the highest number there are Haitians without a history 
of homosexuality or intravenous drug use. 

Dr. Sencer. Let me try and explain this. 

Mr. Walker. Fine. 

Dr. Sencer. We feel that there is a good scientific explanation 
for the transmission of disease in the homosexual male population, 
in the IV drug abusing population, and in the hemophiliacs. In the 
Haitian population, we still do not know what the mode of trans- 
mission is. And so, therefore, we are saying that this is a group 
that is under investigation, that we do not know — we lack informa- 
tion rather than anything else on this population. 

We have had some of our Haitian individuals in New York City 
who have been diagnosed as being drug abusers, and at that point 
they are removed and placed in the category of an IV drug abuse 
patient. A few of them have also been diagnosed as being homosex- 
ual males, and they are then included in that population. 

It could be that this will end up with a residual in which we will 
not be able to determine what the risk factor is. But our attempt 
has been to describe the principal risk factors by the modes of 
transmission that we know of at the present time. 

Mr. Walker. Would you recommend that the Federal Govern- 
ment take the Haitians off as a risk group? 

Dr. Sencer. I think that it depends upon how the Federal Gov- 
ernment desires to describe the risk group. I think that one of the 
nice things about scientific investigations is that you can have 
honest differences of opinion. It is my feeling that until we find out 
the method of transmission of the disease within the group, I don't 
think that they should be included as a risk group. 

You will notice that we have sexual partners of at-risk groups in 
that situation, too. Most of these are sexual partners of IV drug 
abusers. And we cannot be sure beyond doubt that it may not be 
from some sharing of needles that have not been reported. So this 
is a group in which we are trying to determine what the mode of 
transmission is. 

Mr. Walker. Thank you. 

Dr. Silverman, you put a great deal of emphasis on the preven- 
tion, which I think is very encouraging. Could you be more specific 
about what you would recommend to an individual who wants to 
avoid AIDS? 

Dr. Silverman. The prevention for individuals — you mean what 
actions people can take? 

Mr. Walker. What actions people can take that would reduce 
the risk. 

Dr. Silverman. I believe the obvious one with the IV drug 
abusers is hopefully not to keep shooting up drugs. But, if you do, 
use clean needles, sterile needles. That probably is not going to 



282 

take place. But I feel that as long as those needles have to be 
gotten surreptitiously, they are going to be contaminated, and that 
is always going to be a problem. 

With regard to sexual practices, I consider most important is not 
sharing bodily fluids; and specifically we are talking right now spe- 
cifically — though all fluids are suspect — about semen. And the use 
of a condom, though not a guarantee, can certainly reduce, the ex- 
change of bodily fluids. 

I believe that knowing your partners is an important factor in 
the transmission or in the control of the transmission of any sex- 
ually transmitted disease, and I don't think this one is any differ- 
ent than other sexually transmitted diseases. And knowing your 
partner is helpful, not only to individual, but it also helps us in 
public health when we are trying to track down the spread of dis- 
ease, to know the contacts. 

Mr. Walker. Mr. Matek, you were critical of several Govern- 
ment processes, and specifically with regard to the administration. 
But you also included in your statement some criticism of the cate- 
gorical funding process that Congress uses. 

Could you be more specific about that? 

Mr. Matek. Well, my perspective on that comes from years in 
administration, trying to find ways to be flexible, to meet local 
problems, and working with Federal regulations and programs 
which have rather strict boundaries. There is a popular school of 
thought in health administration that would propose the break- 
down of these categorical programs, and allow people at State and 
regional levels to coordinate programs based on local needs. This is 
difficult to do when you have categorical funds. 

One of the proposals made for AIDS is that there be a separate 
AIDS funding program similar to the end-stage renal disease pro- 
gram. And, of course, when you propose a program like that, 
people in my field tend to say, "Oh, no, not another one!" 

What I am suggesting is that, yes, it may indeed be necessary to 
have yet another one, at least this time. And I would hate to see us 
try to use this problem as the occasion for system-wide reform, be- 
cause system reform just takes too long. This is an epidemiologic 
emergency. We don't have any time to waste. 

Mr. Walker. I understand that. But it sounds as though what 
you are saying is that the administration moving toward block 
grant proposals in some of these fields, including the health field, 
does in fact have some merit with regard to application in local 
areas and making certain that money can be used in a responsive 
way when these emergencies arise in local areas. 

Mr. Matek. The block grant concept could be useful relative to 
AIDS in a limited sense. And that would be in providing money for 
local treatment, money to local health departments for education, 
and prevention activities, and possibly certain kinds of applied re- 
search. However, to get at the issues epidemiologically and scientif- 
ically now, we need to be working primarily through CDC and 
through the National Institutes of Health in a focused way. 

So I see Federal level involvement as the priority of the moment, 
which is not to say that block grants wouldn't be useful down the 
line. 

Mr. Walker. Thank you, Mr. Chairman. 



283 

Mr. Weiss. Mr. Conyers. 

Mr. Conyers. Thank you, Mr. Chairman. 

I am going to have to ask to be excused. There is a whip check in 
the Speaker's office on the Martin Luther King bill today. 

Mr. Weiss. We are glad you could spend any time at all with us 
today. 

Mr. Conyers. I want to commend the witnesses I have heard. 
There could hardly be a more thoughtful presentation made by 
them. And I think the chairman's description of the problem is one 
that does not beg any difference of view. 

Here we are in an American political system, intelligently dis- 
cussing an acute emergency. We have come up with — I counted 
seven reasonable ways to move on the problem. And the issue that 
is raised, of course, is what in God's name are we going to really do 
and what is going to happen after today's session. 

I suppose like all emergencies, this requires special action. I 
won't argue with that. The 200,000 people starving in Detroit re- 
quire special action; 11 million people out of work require special 
action. We have got lots of requests for special action. This is one. 
And standing on its own merit it should be treated that way. 

But to think that we are going to whip through intelligently, 
through this screwed up system, just because of this emergency, is 
to intelligently beg the question, because we are going to have to 
make changes in who pays and who decides what actually happens 
and who pays for not deciding what actually happens. 

This is a political question, like every one of the others that we 
are presented with. And so I am not quite so sure if this issue 
should not be made the basis for the reform of the systems. It must 
be. It must be treated specially, as well. 

What in God's name can people in Government say to you when 
we spend $900 billion a year of the people's money, a quarter of it 
going on weapons of insanity that further destabilize the planet, 
when we meet here in this room and discuss a very critical health 
problem? And I think that it has to be a call to action for not just 
those victims and their friends and those who intelligently under- 
stand this as a medical-social problem, but somehow we have the 
responsibility to teach the rest of the American people that this 
critical problem has to be part of the systemic reform. It has to be 
part of the understanding that goes into making this a more liv- 
able Nation and, in the end, a more livable world. 

So I am prepared to bring this issue down to brass tacks. I am 
going to be very sympathetic to all the Federal witnesses. I am 
hoping that our former colleague, Mrs. Heckler, will on the advice 
of her many friends on this subcommittee choose to intervene in a 
way that is in keeping with her spirit as a Congresswoman — we 
worked together for many years — that we really break through im- 
mediately on an emergency basis and systemically as well. And 
then those of us, if we succeed, join with the other challenging 
social problems that are here; and if we don't succeed, I think we 
have to do what is mandatory in our society. 

It has to become part of the political decisionmaking as to who 
represents you locally and nationally. Because unless that part is 
added on to it, unless this dimension is honestly discussed here, we 
are really being superficial. We are acting like somehow, some- 



284 

where, somebody else is going to miraculously solve the problem. 
We, in this room, are the people whose intelligence and energies 
are going to determine what actually happens. 

I invite the witnesses to make any response they choose. 

Mr. Matek. Mr. Congressman, I understand what you are sayir 
and I agree with you. Again, we will just put out the fact th{ 
APHA is ready to do whatever it is we are asked to do. 

Dr. Silverman. That is also certainly true of the local health o 
fleers. I am speaking for the U.S. Conference of Local Health Off 
cers. I think there is one other thing, if I might mention, that 
think is most important. It hasn't been addressed today. That i 
what some people have termed the second epidemic, and that is th 
anxiety which has grown up around this disease. 

I spend probably as much or more time trying to deal with tha 
as I do with the prevention of the spread of the disease in the al 
fected communities. I think it goes to something that Stan said. I 
is most important that there be a coordinated effort from CDC an( 
the local health officials and APHA, in the dissemination of infor 
mation, because, as information comes out, sometime if it is no 
carefully put out or if it is put out before it probably should be, w( 
fuel the flames of this anxiety, and the social impacts of that are 
incalculable. 

Dr. Sencer. Mr. Conyers, I am touched at your concern over this 
as a major social problem. 

Dr. Silverman talks about the epidemic of anxiety. I think this is 
being fueled by an epidemic of homophobia. It is giving people whc 
disapprove of a certain lifestyle an opportunity to come forth and 
be against that by picking on the disease rather than venting their 
spleen, their bile, upon something that they disagree with. 

I think that it is reminiscent of the problems of the 1960's and 
the civil rights movement. I think that if anything good comes out 
of our struggles against the disease, it may be a better understand- 
ing of the rights of individuals to their own lifestyles. It is very 
troublesome to see the sorts of things that are proposed in public 
forums and in the newspapers. It is going to take leadership at all 
levels to try and combat this. 

Mr. Weiss. Thank you very much. 

Thank you, Mr. Conyers. 

Mr. Matek. Mr. Chairman, it just occurred to me as my col- 
league spoke that it might be helpful for the members of the com- 
mittee to invite comment from the National Institute of Mental 
Health on what it is they plan to do relative to the issue of stress 
and anxiety as connected to this problem. 

Mr. Weiss. Thank you. 

Mr. McCandless? 

Mr. McCandless. Thank you, Mr. Chairman. 

I certainly agree that society should be concerned. But I would 
also point out that those of you who consider this some kind of a 
back-breaking, all-out emergency, that there is another disease 
that has been on the face of the Earth for quite some time that I 
am very concerned about, and that is cancer. 

I would like to be more specific, though. 

Dr. Sencer, you mentioned in your opening remarks, and then 
followed up in one of your addendums, on page 3, the statistical 



285 

analysis of AIDS cases by mutual exclusive risk groups in New 
York City. This then was broken down into three categories. 

You have your homosexual-bisexual males, which encompasses 
70 percent of the cases. Second, there are the IV drug users, with 
no history of homosexuality, which represents 22 percent of your 
total group. Third are hemophiliacs, which you have none at this 
time. And finally, there are the others or unknown category which 
number 76, and are 8 percent of the total. 

Can you expand on this, as to who might be in this last group? 

Dr. Sencer. Yes. It is in the table just below that, where, of that 
76, 31 are individuals who are of Haitian origin, who do not have a 
history of homosexuality or drug abuse. There are 14 that died 
before they were interviewed, so we have no adequate information. 

Mr. McCandless. Was this determined by an autopsy? 

Mr. Sencer. These are people who were diagnosed as having 
AIDS, but there was not an interview conducted to determine 
whether there were IV drug abuse patterns or homosexuality. Most 
of these were in the early days of the disease when the risk factors 
were not associated. 

Kaposi's Sarcoma is a disease that occurred at a level of about 
two to three cases a year in New York City, prior to the current 
outbreak we are seeing. It has a different age distribution. It is 
mainly in older males of Mediterranean origin. And we think that 
because of the way the definitions are set up, these two cases are 
probably background cases rather than involved with the epidemic. 

At the present time there are three people whose only risk factor 
may have been the blood transfusions. And we are investigating 
those at the present time. 

As I mentioned, we have 12 individuals who are sexual partners 
of individuals in the at risk. One of those was a woman whose 
sexual partner was a bisexual male who developed AIDS. The 
others, all except two on which we have no adequate history, are 
sexual partners of IV drug abusers. And here you are always left 
with a little bit of wonder whether there may also be some sharing 
of the needle in the home. 

And then there are 14 that we have under investigation at the 
present time which we have not yet come to a conclusion on. 

Mr. McCandless. Would you say there is a medical parallel be- 
tween the increase in AIDS and that of venereal disease? 

Dr. Sencer. No, sir. As a matter of fact, one of the things that 
gives us some hope that there is a change in patterns that Dr. Sil- 
verman was mentioning, the occurrence of infectious syphilis and 
gonorrhea in the one large area of New York City that serves prin- 
cipally the homosexual male population, incidence of these two ve- 
nereal diseases is down. And we believe that this may be an indica- 
tion that there is some lifestyle change. 

There are similarities in that we know that with venereal dis- 
ease the person who has multiple sexual partners, particularly un- 
known sexual partners, anonymous sexual partners, is more likely 
to develop venereal disease than those who have a single partner 
or fewer partners. And this has been part of the advice that origi- 
nates within the gay groups themselves. 

The Association of Physicians for Human Rights has recommend- 
ed that gay males limit the number of sexual contacts, particularly 



26-097 O— 83 19 



286 

with anonymous individuals. So I think this is bringing about some 
change at least in New York City of the lifestyle. 

Mr. McCandless. Dr. Matek, you have emphasized the emergen- 
cy that faces us. I think you used the word "catastrophic" at one 
point. Maybe I am misinformed but your emphasis seems rather 
strong. Could you define to what extent you consider this an emer- 
gency? 

Mr. Matek. Congressman, the urgency I feel is based on the epi- 
demiological character of this problem and on our lack of knowl- 
edge about the basic mode of functioning for this disease, its mor- 
phology. The death rate from AIDS is the highest of any disease 
with which we are currently dealing. That is the basis on which I 
consider it urgent. 

Second, we know not what it is, where it comes from, how it gets 
where it goes, and where it is going from there. When you recall 
that this is a disease with an incubation period of 1 to 2 years, the 
next question is: how long during that incubation period is the dis- 
ease transmissible? And how many people are exposed during those 
12 to 24 months by each carrier? 

The possibilities are phenomenal. The implications are devastat- 
ing, given the high cost of treatment and the high death rate. So 
we in APHA are concerned that we are dealing with the small tip 
of a very large iceberg. 

Mr. Weiss. The gentleman's time has expired. 

Mr. McCandless. Thank you, Mr. Chairman. 

Mr. Weiss. Mrs. Boxer? 

Mrs. Boxer. Thank you, Mr. Chairman. 

I want to thank the panel for being so direct and responsive to 
questions. 

Dr. Sencer and Dr. Silverman, you are really in the trenches. 
You are really there. And from your reports, I think you are just 
doing an exceptional job. But I get the feeling that you are there 
really by yourselves in terms of the cities handling the problem. 

What I would like you to tell me, if you can try to put this into a 
percentage, we know how much you are spending from local funds 
on the disease, what percentage of the effort that is being expended 
in your cities can you attribute to the Federal Government, be- 
cause one of our purposes here is to assess how helpful we are 
being in this whole fighting of this disease. And I wonder, Dr. Sil- 
verman, if you can give me a guesstimate of the percentage of the 
effort in San Francisco that you can say is directly attributable to 
the Federal Government? 

Dr. Silverman. We have now in San Francisco at this time at 
least one representative from CDC helping us in our epidemiologic 
investigations. If you eliminate that, you eliminate pretty much 
the Federal input into the funding for this — for our problems. It is 
probably 98-plus percent local funds. 

Mrs. Boxer. What was the first year that this whole issue of 
AIDS was called to your attention as being a serious problem? 

Dr. Silverman. We started getting involved in 1981, and really 
in large part almost a department-wide effort, in 1982. 

Mrs. Boxer. So from 1981 to 1983 you can state that the attack 
on AIDS has been launched by the city and county of San Francis- 
co, up to 98 percent of the effort? 



287 

Dr. Silverman. I think that would be a fair estimate. 

Mrs. Boxer. Dr. Sencer? 

Dr. Sencer. Doing a quick calculation, we have a contract with 
CDC for $125,000. We have two epidemiologists assigned to the city 
health department who are working full time on AIDS; their 
salary, probably another $100,000. We have a public health adviser. 
So I think probably roughly $250,000 of direct support comes from 
the Federal Government. That is out of our estimated health de- 
partment. 

I am not talking about hospitals or diagnostic service. About 25 
percent may come from Federal assistance. 

Again, part of that $100,000 — part of the costs of one of the epi- 
demiologists is not directly from CDC. It is the one opportunity we 
have had to use the block grant. 

Mrs. Boxer. Okay, you don't have to go into specifics. We can say 
about 75 percent of the effort 

Dr. Sencer. Local money. 

Mrs. Boxer. Has been from the city of New York in this case? 

Dr. Sencer. That is right. 

Mrs. Boxer. I just want to state, Mr. Chairman, I think this is 
shocking information, absolutely shocking. And it is very impor- 
tant information for us to know. And I would like to ask Mr. 
Matek something. And I particularly want to thank you, because I 
think you gave us some very concrete ideas as to what to ask our 
Federal people here. 

I have heard, and this is not something I have seen, but I have 
heard that the White House is going to come in with a recommen- 
dation that $18 million be allocated for next year. I can tell from 
the answers of the panel that that would not be anywhere near 
adequate. 

I want to ask you, Mr. Matek, in your experience has there ever 
been any other public health emergency that you know of in this 
country where the health people in the Federal Government have 
had to be pushed so hard by outside groups, by Members of Con- 
gress? It is my feeling, having served in local government, we the 
elected officials are always being pushed by the health profession- 
als, but in this case, as you pointed out, it is Members of Congress 
that seem to be pushing on the health professionals. 

Do you know of any other example where this has been the case? 

Mr. Matek. Eighty-five years ago it was the American Public 
Health Association that pushed the President to send Walter Reid 
to Cuba. Since that time there has not been such a dramatic incon- 
sistency between public health goals and administration goals as 
now exists. We understand the pressures on the economy. We un- 
derstand the priorities of the Administration. But we need to point 
out the inconsistencies which exist in this case. 

I do not know of other similar examples. But in all candor, I 
must confess I don't know of similar circumstances either. 

Mr. Weiss. The gentlelady's time — Dr. Silverman. 

Dr. Silverman. Just a quick one. 

The subject came up, why the emergency? I think when we talk 
about 1,800, maybe 2,000 individuals, that looks small. But right 
now it is universally fatal. And it is the snuffing out of young peo- 
ple's lives, not that one can place a value at any age level. But here 



288 

are people in their most productive time of life, who should be pro- 
viding services back to the communities and workmg actively in 
the community. And these are just the people who are dying. I 
think with that mortality rate, it is a real emergency. Maybe the 
problem is that the Federal Government in the past has been look- 
ing at the number rather than the problem itself. 
Mr. Weiss. Thank you, Mrs. Boxer. 
Mr. Craig? 

Mr. Craig. Thank you very much, Mr. Chairman, and to all of 
you panelists. I appreciate your testimony, and the depth of it. 
A couple of questions. . 

Dr. Sencer, we heard yesterday some figures that, by their sur- 
face and by their composition, are startling and important in the 
consideration of this issue— that the reported or diagnosed cases 
are doubling approximately every 6 months. That figure was used 
by several professionals yesterday. 

Apparently they are using national averages, based on the infor- 
mation that is available and that is now currently being collected. 
In looking at your addendum on page 1— speaking of trends of 
AIDS cases by month in New York City— you don't seem to demon- 
strate, based on the 1982 monthly average of 42 versus the 1983 
monthly average of 50, to be experiencing that kind of doubling 
effect. 

I guess the best thing then to ask you is, what are you seeing in 
your city as to the increase factor, or the ratio, of increase? 

Dr. Sencer. As you point out, for the ^.ast 2 months we have been 
talking about the fact that it does not appear to be increasing as 
rapidly in New York City. Still 50 new cases a month is certainly a 
matter of continued concern. 
Mr. Craig. Absolutely. 

Dr. Sencer. It may be that our reporting is not as good as we 
would hope to be, and this is why we are undertaking an intensive 
review in conjunction with the hospitals of New York, of the diag- 
noses, to see whether we are missing cases. 

It could be the fact that some of the advice that Dr. Silverman 
was talking about is being heeded, that there is a change in life- 
style that puts people at less risk. It could be that the disease is not 
as infectious as we had once feared that it would be. 

Pure speculation would be that perhaps there are enough sub- 
clinical cases, people who do not actually become ill, who develop 
an immunity to the disease. 

I know that it is continuing to increase in other parts of the 
country. It may be that the disease has not been there and is being 
seen more now. But we in New York at the present time are in a 
bit of a plateau. I could go home tomorrow and find it is up again. I 
certainly hope not. We do not see the doubling at the present time. 
Mr. Craig. Dr. Sencer, you say you are going to review your in- 
formation-collecting capability within the next couple of weeks? 

Dr. Sencer. Yes; what we are doing is reviewing diagnoses in 
hospitals to see whether there are laboratory diagnoses that have 
not been reported. 

Mr. Craig. Could you make available to this committee that in- 
formation, if you find the trends you indicated here have substan- 
tially changed or need correction? 



289 

Dr. Sencer. It will be well-known, sir; yes, sir. 

Mr. Craig. Also, Dr. Sencer, I was, frankly, a little surprised, but 
pleased, to hear of the frankness of Dr. Silverman as it relates to 
what he feels these communities ought to be doing as a preventive 
approach to this problem while we struggle with getting on with 
trying to find some cure and/or method of prevention through in- 
oculation or whatever. 

I am not trying to place any higher level of importance on what I 
am about to ask. I see the aforementioned subjects as two separate, 
but jointly very important things, in the total problem. 

I assume that you and Dr. Silverman, and if you are not I wish 
you would indicate, doctor, in the San Francisco Department of 
Public Health are communicating very loudly and clearly to the 
communities involved what your recommendations as to how they 
live their lifestyles ought to be conducted in a preventive way. 

Are the city of New York and the health departments of New 
York, approaching this in a similar fashion? 

Dr. Sencer. I think that our approach in New York has been — I 
wouldn't say loud, but we have tried to work with the various pop- 
ulation groups at risk to get them to bring out the recommenda- 
tions on behavior rather than this being something that comes 
down from city hall or from the health department. 

As San Francisco has done, we have met with the owners of 
bathhouses to convince them to develop their own types of stand- 
ards for education within this particular mileu. As I mentioned, we 
meet biweekly with the affected communities, as San Francisco 
does. We have a full-time office of gay and lesbian health concerns 
that helps in this communication to the population group affected. 

Mr. Weiss. Thank you, Mr. Craig. 

Mr. Craig. Could I have one last followup on this question? 

Mr. Weiss. Very, very brief, please. We have had Dr. Brandt 
waiting for an hour. 

Mr. Craig. As you come to us and encourage increased levels of 
Federal support into the millions of dollars, which I am certainly 
sympathetic to based on the scope, the magnitude and the un- 
knownness of this problem, don't you believe there is some level of 
responsibilty at the public health level — not to be quiet about prac- 
tices or alternative lifestyles as it relates to this problem, but that 
maybe you ought to be really quite loud about it — as to what you 
now see as methods of prevention or practices of prevention? 

Dr. Sencer. I think that there are ways in which this could be 
accomplished without taking to the soapbox. 

I certainly believe that the information is going to be better ac- 
cepted and come from a stronger support if it comes from the af- 
fected communities themselves. 

This is not to say that we do not publicly make these statements 
in New York. I have made them, the mayor has made them. It is a 
matter of public record. But I believe that our approach has been 
one of working with the affected groups to try and develop the ca- 
pabilities within — particularly within the gay community to edu- 
cate the people that they can communicate with. There are gay 
newspapers that are a much better communicator to that popula- 
tion than our New York newspapers, the general circulation. I 



290 

think that it is through working with this approach that we can 
accompHsh our goals. 

I think that pubHc exhortation has not stopped the spread ot ve- 
nereal disease. It has been by making adequate treatment available 
to individuals with venereal disease, it has been by finding cases 
and bringing them to treatment. So I think when we are dealmg 
with a personal behavior of this nature, mere exhortation without 
good epidemiologic assistance to bring them in for adequate diagno- 
sis and treatment has not proven itself to be of much use m vene- 
real disease. 
Mr. Weiss. Thank you, Mr. Craig. 

Dr. Sencer. Mr. Chairman— I am very pleased that this hearing 
is taking place, because here we are talking about the problems of 
communicating about sexual behavior, about sexual patterns. I can 
remember when it was within my lifetime that the Surgeon Gener- 
al was cut off the radio for talking about syphilis. So I think we 
have come a little ways in 50 years. 
Mr. Weiss. The Congress is very bold these days. 
Mr. Levin? 

Mr. Levin. Mr. Matek, in your written testimony you say it has 
been disappointing to hear recent charges of unresponsiveness on 
the part of CDC and NIH related to their AIDS-related activities. 
But such appearances can be understood easily enough by refer- 
ence to the fact that these agencies are underfunded, understaffed, 
and overworked. It is clear, moreover, that the administration's 
marching orders to these program directors is unequivocal— in 
quotes— "Don't ask for any money, make us look as good as you 
can with what you have got." 
Would you elaborate on both of those serious charges? 
Mr. Matek. Those are my conclusions based on observing behav- 
ior over the past 2 years. Those are my conclusions based on re- 
peated discussions with various officials, asking them why certain 
things could not be undertaken in epidemiological research or in 
intervention. 

I have received a uniform answer: "There is no money. We have 
gone to the administration to ask for money and been told no. 
There is no new money for social programs." 

We have witnessed the recommendations of 0MB over two 
budget periods now, consistent with that principle, that policy com- 
mitment. And we are now observing the budgetary consequences 
within our operating programs. 

I am left with no other conclusion. Congressman, and I wish that 
someone would prove me wrong. I certainly invite the White House 
to come forward and show me that I am wrong. 
Mr. Levin. Thank you. 

Mr. Weiss. Thank you very much, Mr. Levin. 
Gentlemen, I want to again express my appreciation for the work 
that you are doing in your own communities and across the coun- 
try, and for giving us the benefit of your knowledge and of your 
experience. 
Thank you. 

Our next panel is the panel from the Department of Health and 
Human Services: Dr. Edward Brandt, Assistant Secretary for 



291 

Health, and Dr. William Foege, Director, Centers for Disease Con- 
trol, are our chief witnesses. 

I understand that they are accompanied by a number of their as- 
sociates and colleagues who will be in the front row behind them or 
accompanying them at the witness table, as you so please, Dr. 
Brandt and Dr. Foege. 

Just identify the people who are with you if you will, so that the 
reporter and those of us up here will be able to know who is speak- 
ing at any particular time. 

Dr. Fauci, Deputy Clinical Director, National Institute of Allergy 
and Infectious Diseases; Dr. Henney, Deputy Director, National 
Cancer Institute; Dr. Quinnan, Director, Division of Virology, 
Office of Biologies, Food and Drug Administration; Dr. Chernoff, 
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute. 

I understand that Mr. Thomas Donnelly, Assistant Secretary for 
Legislation, is also in the audience. Since we will be getting into 
some issues with which he has been involved, I think it would be 
helpful for him to join the other panelists at the witness table. 

Before we start, let me just indicate how pleased I am that we 
have this opportunity to discuss with Department officials some of 
the concerns that have been expressed in the last day and a half as 
well as to explore some of the issues which the subcommittee has 
been examining over the course of these past 8 or 10 weeks. 

Let me first start by swearing you in or offering the affirmation. 

Would you all stand? 

Do you swear or affirm to tell the truth, the whole truth, and 
nothing but the truth? 

Let the record indicate that each of the witnesses has so indicat- 
ed. 

Dr. Brandt, as you know, we have your prepared statement. It is 
very long and very detailed, and we welcome it. It will be entered, 
without objection, into the record in its entirety. 

Because of time constraints, the subcommittee would appreciate 
if you would try to summarize rather than read the entire state- 
ment. That way we would be able to spend the bulk of our time 
with questions which I know I and the other members of this panel 
have. 

Let me indicate at this point that we have had some concern 
which we will be getting into in greater depth as the hearing goes 
on regarding the obligations and responsibilities of this subcommit- 
tee toward not just you individually, but the Health and Human 
Services Department and its various subagencies and representa- 
tives. 

As you may know, this committee, the Government Operations 
Corrimittee, of which we are a subcommittee, was created specifical- 
ly to provide oversight for the various programs not only in the 
health field, but in all fields of Government, to see how programs 
which Congress enacted are being implemented, how they are 
working, which programs are effective, which are not, how the re- 
sponsibilities are being discharged by those people in the executive 
branch who have been delegated to deal with those programs. 

I understand that most executive branch staff, not only in this 
administration but in every administration that I have been famil- 



292 

iar with at all levels, Federal, State, and local, view the ideal over- 
sight as being a situation where they come in and tell us what a 
wonderful job they are doing, and we let it go at that. 

We view the responsibility somewhat differently. Our responsibil- 
ity is in fact to go out and check to see what kind of job you are 
doing. That means and has meant since the beginning of this Re- 
public the right of Congress and its committees and subcommittees 
to reach into the agency, to have access to the personnel of those 
agencies, to have access to the files of those agencies. The right of 
Congress to that access has been repeatedly affirmed by the Su- 
preme Court and other courts that have dealt with it. This matter 
is really not at issue, not in doubt. 

I must tell you that it has been a difficult experience over the 
course of these last 10 weeks to experience what in essence has 
been stonewalling from Secretary Heckler on down in our efforts to 
discharge our responsibilities. As I say, we will be going into specif- 
ics and details as we go along. 

At this time. Dr. Brandt, I would welcome your testimony. 

STATEMENT OF DR. EDWARD BRANDT, ASSISTANT SECRETARY 
FOR HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERV- 
ICES, ACCOMPANIED BY DR. WILLIAM FOEGE, DIRECTOR, CEN- 
TERS FOR DISEASE CONTROL; DR. JANE HENNEY, DEPUTY DI- 
RECTOR, NATIONAL CANCER INSTITUTE; DR. ANTHONY FAUCI, 
DEPUTY CLINICAL DIRECTOR OF INTRAMURAL RESEARCH, NA- 
TIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; 
DR. AMOZ CHERNOFF, DIRECTOR, DIVISION OF BLOOD DIS- 
EASES AND RESOURCES, NATIONAL HEART, LUNG, AND BLOOD 
INSTITUTE; DR. GERALD QUINNAN, DIRECTOR, DIVISION OF 
VIROLOGY, OFFICE OF BIOLOGICS, FOOD AND DRUG ADMINIS- 
TRATION; AND THOMAS DONNELLY, ASSISTANT SECRETARY 
FOR LEGISLATION, DEPARTMENT OF HEALTH AND HUMAN 
SERVICES 

Dr. Brandt. Thank you very much. We appreciate the opportuni- 
ty we have to discuss with you the acquired immune deficiency 
syndrome [AIDS]. 

You have already recognized my colleagues, Mr. Chairman. You 
are correct that we do have long and complex testimony. And I will 
attempt to summarize it, yet try to make what I consider to be 
some of the more important points. 

AIDS has been officially recognized by Secretary Heckler as the 
Department's highest priority emergency health problem. During 
the past 2 years, AIDS has caused suffering and death in far too 
many people. 

AIDS is a recently recognized health problem which is character- 
ized by a severe and persistent breakdown in part of the immune 
system. 

For epidemiologic purposes, CDC defines an AIDS case basically 
as an individual: First with a reliably diagnosed disease that is at 
least moderately indicative of underlying cellular immune deficien- 
cy, and second with no known underlying cause for that deficiency 
or any other cause of reduced resistance reported to be associated 
with that disease. Persons with AIDS are susceptible to some tj^es 



293 

of cancer, such as Kaposi's sarcoma and other B cell lymphomas, 
and a variety of life-threatening infections, the most common of 
which is Pneumocystis carinii pneumonia. There has been no case 
reported in which the immune system of an AIDS patient has re- 
turned to normal. 

From June 1981 until July 26, 1983, the Centers for Disease Con- 
trol has received reports of 2,044 persons with AIDS — 122 of these 
cases were reported from 20 foreign countries. In the United 
States, 1,922 cases have been reported from 39 States, the District 
of Columbia, and Puerto Rico. A complete breakdown by State is 
included in the testimony. 

The average age of AIDS victims is 35 years; 93 percent are men. 
Death has been reported in at least 743 or 39 percent of the 1,922 
cases. Of the 598 people diagnosed more than 1 year ago, almost 
two-thirds have died. 

To date, reported cases fall into five categories: homosexual or bi- 
sexual men with multiple sexual partners, intravenous drug 
abusers, persons of Haitian origin, persons with hemophilia, and 
others. Eighty-eight percent of the reported cases from the United 
States fall into the first two risk groups. Because sociocultural dif- 
ferences may lead to problems in obtaining sensitive information 
from Haitians residing in the United States, the apparent lack of 
overlap between the Haitian and other groups must be interpreted 
cautiously. 

The 6 percent of patients who have not been placed in any of 
these groups are the subject of intensive investigation. Included in 
this group are 19 people who are sexual partners of risk group 
members, 17 patients who received blood transfusions within 3 
years of becoming ill, 10 patients who have Kaposi's sarcoma but 
normal immunological studies, and 15 individuals on whom com- 
plete medical histories have been obtained but who cannot be fur- 
ther classified in relation to known high risk groups. The remain- 
ing cases have been reported in individuals on whom complete 
medical histories could not be obtained. 

The Federal response to AIDS began in June 1981 with the inves- 
tigation and subsequent publication in CDC's Morbidity and Mor- 
tality Weekly Report (MMWR) of the first five cases reported from 
Los Angeles. Medical epidemiologists were immediately dispatched 
from CDC to investigate additional cases in New York City and 
California. 

The admission of the first AIDS patient to the Clinical Center at 
the National Institutes of Health occurred on June 16, 1981, ap- 
proximately 11 days after the first cases were reported in the 
United States. Subsequently, the FDA and the Alcohol, Drug 
Abuse, and Mental Health Administration became actively in- 
volved in the AIDS investigation. Because of the extensive multia- 
gency involvement, I appointed a Public Health Service Executive 
Committee on AIDS to formalize coordination of the response of 
these agencies to the AIDS problem. 

Because there are gaps in our understanding and because of the 
complex nature of AIDS and AIDS investigations, the public is ap- 
propriately concerned about AIDS and the Public Health Service's 
response to this problem. Therefore, it may be useful to review 
some of the specific questions that have been raised by the public. 



294 

We believe AIDS is transmitted sexually; less frequently through 
transfusion of blood or blood products; or by the misuse of needles. 
There is no evidence that the disease is spread through air food, 
water, or other casual contact. On the contrary, AIDS is a ditticult 

disease to contract. , , , . o ■ 

The risk of acquiring AIDS through a blood transfusion is ex- 
tremely small. We do not yet know the cause of AIDS, but the evi- 
dence is strong that we are dealing with an infectious agent with a 
long incubation period. The most plausible agents are viruses. 

Treatment is available for Kaposi's sarcoma and for some of the 
infections which affect AIDS victims. Though a cure is not present- 
ly available, we are convinced that steps can be taken to prevent 
the acquisition of AIDS. And in March 1983, we published our rec- 
ommendations in the MMWR. 

All collected information used to identify an individual patient is 
generally protected under the provisions of the Privacy Act. CDC 
has a longstanding position of protecting patient confidentiality, a 
position which has been upheld many times in the courts. Howev- 
er, because of recent concerns expressed in the press and by some 
State and local health officials, a system is being developed by CDC 
whereby information on new AIDS cases will be reported to CDC 
with all identifying information deleted by health departments and 
the case identified by a code number. 

As to expenditures, the Public Health Service spent $5.5 million 
directly on AIDS in fiscal year 1982 and will spend $14.5 million in 
fiscal year 1983. In addition, the recently signed supplemental ap- 
propriations bill provides an additional $12 million for obligation in 
fiscal 1983 and fiscal 1984. 

To address these and other public health concerns, the Public 
Health Service has established a national AIDS hotline and has 
made a factsheet and biweekly information package available to 
the public and to the professions. 

With your permission, Mr. Chairman, I would like to submit for 
the record copies of the material used on the hotline as well as the 
factsheet and the most recent biweekly information package. 

On May 24, 1983, I issued a press release to clarify the hazard of 
AIDS and the status of Public Health Service efforts in combatting 
the AIDS problem. Let me now present the Public Health Service 
operational plan which we have followed in attempting to solve the 
AIDS problem. 

First, I'll talk about CDC. The activities of the CDC fall into four 
major areas: surveillance, epidemiologic studies, laboratory investi- 
gations, and dissemination of information. 

Using epidemiological studies, CDC has sought to determine risk 
factors and modes of transmission for AIDS. Laboratory work has 
been in the areas of immunology and infectious diseases. CDC has 
disseminated timely information to medical and public health per- 
sonnel and the general public about the AIDS problem. Between 
June 1981 and July 1983, 21 articles related to AIDS have appeared 
in the Morbidity and Mortality Weekly Report. 

Turning now to the NIH, it is supporting a wide range of AIDS 
research by its own scientists and by university and private investi- 
gators. Collaborative as well as independent research efforts have 
been undertaken both intramurally and extramurally by the Na- 



295 

tional Cancer Institute (NCI), National Institute of Allergy and In- 
fectious Diseases (NIAID), National Heart, Lung, and Blood Insti- 
tute (NHLBI), National Institute of Neurological and Communica- 
tive Disorders and Stroke (NINCDS), departments of the NIH Clini- 
cal Center, and other components of the NIH. 

Thus far, 69 AIDS patients have been treated at the NIH Clinical 
Center, of whom 15 have died. 

Extramural activities have included the issuance of two requests 
for applications (RFA's) jointly sponsored or funded by the NCI and 
the NIAID. The purpose of this recent RFA, entitled "Infectious 
Etiology of Acquired Immune Deficiency Syndrome and Kaposi's 
Sarcoma," is to encourage studies on the search for the isolation 
and the characterization of the biological agents which may be the 
primary causative factor in AIDS and Kaposi's sarcoma. 

There are more than 30 individual research projects within the 
intramural laboratories of NIAID which directly relate to AIDS. 
The NIAID intramural program has recently awarded a contract to 
the New York Blood Center to obtain specimens of blood, semen, 
feces, and saliva from several groups of individuals considered at 
high risk of acquiring AIDS. These specimens will be obtained reg- 
ularly and stored. If AIDS develops in any of the studied partici- 
pants, these specimens will provide valuable material for many of 
the projects concerned with determining the etiologic agent, devel- 
oping detection methods, and studying modes of disease transmis- 
sion. 

Four applications have been funded in response to the NCI re- 
quest for application on AIDS research that was issued in August 
1982. Other funds support research project grants not submitted in 
response to the RFA, including the effects of cytomegalovirus on 
cell-mediated immunity, plus AIDS projects at ongoing NIAID Sex- 
ually Transmitted Disease Centers and Centers for Interdisciplin- 
ary Research on Immunologic Diseases. 

NCI intramural activities can be divided into research concerned 
with AIDS and peripheral research examining the immune system 
from a broader perspective. NCI has called upon a variety of re- 
sources in an effort to respond quickly. Mechanisms of response 
and support include grants, cooperative agreements, and contract 
awards, the development of specialized RFA's, special workshops, 
the establishment of an extramural working group, and presenta- 
tions to and discussions with the NCI advisory bodies. 

In September of 1981, roughly 4 months after this disease was 
first defined, the NCI sponsored a workshop on AIDS involving 
NCI-supported scientists, along with NCI staff. The workshop was 
developed for the NCI's Division of Cancer Treatment Board of Sci- 
entific Advisers. Three meetings have taken place recently. One of 
these brought together all of the cooperative agreement grantees. 
Two meetings involved the combination of NCI AIDS intramural 
task force staff and outside Federal and university scientists active 
in the area of retrovirus and AIDS. 

The NCI continues to encourage investigator-initiated grant ap- 
plications and expedites the review of any applications related to 
AIDS that are received. NCI has formed an extramural working 
group which consists of all NCI funded grantees and includes NCI 
and other NIH staff with participation from CDC. This group 



296 

meets regularly to discuss ongoing research and share preliminary 

NHLBI is primarily involved in two aspects of the AIDS problem. 
One in regard to its responsibility for hemorrhagic disorders, such 
as the hemophilias, NHLBI is concerned with the care and treat- 
ment of these patients with blood and blood products; and two, m 
regard to blood and blood products, the Institute has a major con- 
cern for the safety of these products. NHLBI sponsored a confe^ 
ence on the association of blood and blood product use with AIDS 
on March 15, 1983. It was attended by 35 scientists, clinicians and 
administrators to develop research recommendations for the Insti- 

^With the cosponsorship of the NCI and the NIAID, NHLBI will 
hold a research workshop on the epidemiology of AIDS m Septem- 
ber 1983. A meeting of the inter-agency technical committee on 
heart, blood vessel, lung, and blood diseases and resources which 
focused on the current state of knowledge regarding AIDS was held 
on May 4, 1983. ^, ^ ^^, ^ 

FDA's efforts have been focused in two areas: The safety ot blood 
and blood products with regard to infectious agents transniissible 
through these products; and research directed toward elucidating 
the etiology of AIDS. FDA has issued guidelines to blood collection 
centers on the prevention of AIDS through the screening of donors 

FDA is also working with blood product manufacturers in an 
evaluation of methods which might be applied to clotting factor 
concentrates to increase the safety of their use. Research has been 
performed at FDA regarding the etiology, pathogenesis, and treat- 
ment of AIDS. Studies pertaining to the etiology of AIDS have been 
directed toward studying the significance of herpes viruses in these 

patients. , m j 

A series of workshops have been held involving the Blood and 
Blood Products Advisory Committee, the Office of Biologies staff, 
outside expert consultants, manufacturers and representatives of 
the American National Red Cross, the Council of Community Blood 
Centers, the American Association of Blood Banks, the American 
Blood Resources Association and the National Hemophilia Founda- 
tion. 

Through these collaborative efforts, progress in developing new 
procedures for increasing the safety of clotting factor concentrates 
have been accelerated. One such product is currently available, and 
others are at a late stage of development. 

The National Institute for Drug Abuse is undertaking several in- 
vestigations to study AIDS and drug abusers. A technical review to 
examine issues surrounding risk factors related to drug abuse was 
convened on July 25 of this year. NIDA is developing programs for 
staff education at drug treatment centers and assisting with the 
distribution of other Public Health Service materials. 

The National Institute of Mental Health held a research plan- 
ning workshop yesterday to address the mental health aspects of 
AIDS. Research will be encouraged in several areas. A workshop to 
address the emotional concerns and support needs of AIDS patients 
and health care providers will be held on August 3. 



297 

It is important to recognize that a number of nongovernmental 
organizations have worked with the Public Health Service in plan- 
ning studies of AIDS or in making recommendations for AIDS pre- 
vention, and we have listed some of those on page 25 of my testimo- 
ny. 

Mr. Chairman, members of the subcommittee, let me assure you 
that we are making every effort to cooperate and assist you in 
meeting the subcommittee's responsibilities in a manner which 
does not violate the confidence placed in us by patients, physicians, 
and State and local health officials. 

I appreciate the opportunity to present our story on the AIDS ef- 
forts to the members of this subcommittee. The continuing commit- 
ment of all of our energies is required. I hereby pledge to eliminate 
the suffering and death caused by this problem. 

My colleagues and I shall be glad to respond to any questions 
which you or other members of the subcommittee may have. 

[The prepared statement of Dr. Brandt follows:] 



298 



DEPARTMENT OF HEALTH & HUMAN SERVICES 



Public Health Service 



Office of the Assistant Secretary 

for Health 
Washington DC 20201 



Statement By 



Edward N. Brandt, K.D., Ph.D. 

Assistant Secretary for Health 

Department of Health and Human Services 



on 



Acquired Immune Deficiency Syndrome (AIDS) 



before the 



Intergovernmental Relations and Human Resources Subcommittee 

Committee on Government Operations 

House of Representatives 

Congress of the United States 



August 2, 1983 



299 



Mr. Chairman and Members of the Subcommittee: 

Thank you for this opportunity to discuss with you the acquired immune 
def-iciency syndrome (AIDS). 

I am accompanied by: Dr. William H. Foege, Director, Centers for Disease 
Control; Dr. Amoz I. Chernoff, Director, Division of Blood Diseases and 
Resources, National Heart, Lyng and Blood Institute; Dr. Anthony S. Fauci, 
Deputy Clinical Director of Intramural Research, National Institute of Allergy 
and Infectious Diseases; Dr. Jane Henney, Deputy Director, National Cancer 
Institute; and Dr. Gerald Quinnan, Director, Division of Virology, Office of 
Biologies, Food and Drug Administration. 

AIDS has been officially recognized by Secretary Heckler as the 
Department's highest priority emergency health problem. During the past two 
years, AIDS has caused suffering and death in far too many people. 

AIDS is a recently recognized health problem which is characterized by a 
severe and persistent breakdown in part of the immune system. For 
epidemiologic purposes, CDC defines an AIDS case basically as an individual 
(1) with a reliably diagnosed disease that is at least moderately indicative 
of underlying cellular inmune deficiency, and (2) with no known underlying 
cause for that deficiency or any other cause of reduced resistance reported to 
be associated with that disease. Persons with AIDS are susceptible to some 
types of cancer, such as Kaposi's sarcoma and other B cell lymphomas, and a 
variety of life-threatening infections, the most common of which is 
Pneumocystis carinii pneumonia. There has been no case reported in which the 
immune system of an AIDS patient has returned to normal; fatality rates of 
AIDS cases have been very high. 

From June 1981 until July 26, 1983, the Centers for Disease Control (CDC) 
has received reports of 2,044 persons who have AIDS. One hundred-twenty- two 
of these cases were reported from 20 foreign countries. In the United States, 



300 



1,922 cases have been reported from 39 states, the District of Columbia, and 
Puerto Rico (Figure 1). More than 60 percent of these cases were reported 
from New York City, San Francisco, and Los Angeles. Of the cases from the 
United States, 47 percent were reported in the last 6 months. The average 
number of cases reported per^day has gradually increased during the past year 
from approximately 2 per day to 7 per day presently (Figure 2). The average 
age of AIDS victims is 35 years; 93 percent are men. Death has been reported 
in at least 743 (39X) of the 1,922 cases. Of the 598 patients diagnosed more 
than 1 year ago, almost two-thirds have died. 

To date, reported cases fall into five categories: homosexual or 
bisexual men, intravenous drug abusers, persons of Haitian origin, persons 
with hemophilia, and others. Eighty-eight percent of the reported cases from 
the United States are homosexual or bisexual men or abusers of intravenous 
(IV) drugs (Figure 3). Of the patients who are homosexual or bisexual men, 12 
percent have a history of IV drug abuse. Of patients who are IV drug abusers, 
33 percent are also homosexual men. A much smaller number of- cases has 
occurred in persons of Haitian origin who now live in this country (most of 
whom entered the U.S. within the last five years) and in persons with 
hemophilia. Because sociocultural differences may lead to problems in 
obtaining sensitive information from Haitians residing in the United States, 
the apparent lack of overlap between the Haitian and other groups must be 
interpreted cautiously. 

The 6 percent of patients who have not been placed in any of these groups 
are the subject of intensive investigations. Included in this group are 19 
cases who are sexual partners of risk-group members, 17 patients who received 
blood transfusions within 3 years of becoming ill, 10 patients who have 



301 



Kaposi's Sarcoma but normal Immunologic studies, and 15 Individuals on whom 
conjplete medical histories have been obtained but who cannot be further 
classified In relation to known high risk groups. The remaining cases have 
been reported In Individuals on whom complete medical histories could not be 
obtained. 

The federal response to AIDS began In June 1981 with the Investigation 
and subsequent publication In CDC's Morbidity and Mortality Weekly Report 
(MMWR) of the first five reported cases from Los Angeles. Medical 
epidemiologists were immediately dispatched from CDC to Investigate additional 
cases in New York City and California. These Investigations led to a second 
MMWR report in July 1981 clarifying the national scope of the problem. The 
admission of the first AIDS patient to the Clinical Center at the National 
Institutes of Health (NIH) occurred on June 16, 1981. Subsequently, the Food 
and Drug Administration (FDA) and the Alcohol, Drug Abuse, and Mental Health 
Administration (ADAMHA) became actively involved in the AILS investigation. 
Because of the extensive multi-agency involvement, I appointed a Public Health 
Service Executive Committee on AIDS to formalize coordination of the response 
of these agencies to the AIDS problem. 
Public Concerns 

Before I outline the activities of these agencies, I shall discuss 
briefly several concerns which have been raised by the public. 

Because there are gaps in our understanding of AIDS and because of the 
complex nature of AIDS Investigations, the public is appropriately concerned 
about AIDS and the Public Health Service's response to this problem. 
Therefore, it may be useful to review some of the specific questions that have 
been raised by the public. 



26-097 O— 83 20 



302 



1. How Is AIDS transmitted? 

Based on the best available Information, we believe AIDS Is 
transmitted sexually, particularly among homosexual partners; less 
frequently, through transfusion of blood or blood products; or by the 
misuse of needles. We have no evidence that the disease Is spread 
through air, food, water, or "casual" contact. To the contrary, AIDS 
Is a difficult disease to contract. 

2. What is the risk of acquiring AIDS through a blood tr ansfusion? 
At present, the risk of acquiring AIDS through blood transfusion 
appears to be extremely small. Although as many as 10 million 
Americans received transfusions during the 3 years of the AIDS 
epidemic, CDC Is investigating approximately two dozen AIDS cases in 
which transfusions may be a risk factor. We believe that the PHS 
recommendations Issued in March 1983, which suggested that members of 
groups at increased risk not donate blood, will decrease the current 

risk. 

3. What Is the cause of AIDS? 

Although we do not yet know the cause of AIDS, the evidence is strong 
that we are dealing with an infectious agent with a long Incubation 
period. Public Health Service laboratory scientists are using the 
most sophisticated methods available in the search for this putative 
agent. The most plausible agents are viruses. The absence of illness 
In animals already Inoculated with specimens may be a reflection of 
the long Incubation period or may Indicate that the "AIDS agent" 
affects only humans. Unfortunately, it Is not possible to predict 
when the cause of AIDS will be found. 



303 



4. Is there a cure for AIDS? 

Treatment is available for Kaposi's sarcoma and for some of the 
Infections which affect AIDS victims. However, the persistent inmune 
defect means that many AIDS patients who survive one of the 
complications of the disease are likely to succumb to another of Its 
manifestations. We aVe hopeful that new treatment methods designed 
to improve immune function will result in improved survival or even 
cure. Though a cure is not presently available, we are convinced that 
steps can be taken to prevent the acquisition of AIDS, and in March 
1983 we published the recommendations in the MMWR. 

5. How does the government guard the confidentiality of the sensitive 
information It collects on AIDS patients? 

All collected information used to identify an individual patient is 
generally protected under the provisions of the Privacy Act. CDC has 
a long standing position of protecting patient confidentiality; a 
position which has been upheld many times in the courts. However, 
because of recent concerns expressed In the press and by some State 
and local health officials, a system is being developed by CDC whereby 
information on new AIDS cases will be reported to CDC with all 
identifying information deleted by health departments and the case 
identified by a code number. Patient names already recorded at the 
CDC will be deleted and replaced by a code number. During early 
August all States will be informed of this reporting system. Calls on 
our new hotline are treated confidentially. No individually 
identifiable record of the call is made. 



304 



6. How much is the Public HeaUh Service spendin g on AIDS research? 
The Public Health Service spent $5.5 million on AIDS in fiscal year 
1982, and will spend $14.5 million in fiscal year 1983. In addition, 
the recently signed supplemental appropriations bill provides an 
additional $12 million for obligation in fiscal year 1983 and fiscal 
year 1984 for AIDS activities. We are reassessing continually the 
resources necessary to respond to this problem in fiscal year 1984 as 
new information becomes available. Because AIDS is the top emergency 
health priority of the Department, funds have been and will continue 
to be redirected, as needed, within PHS agency budgets to respond to 
this problem. 
To address these and other public concerns, the Public Health Service has 
established a national AIDS-hotline, and has made a fact sheet and bi-weekly 
information package available to the public. We are distributing over 12,000 
individual copies of the material monthly. In addition, interested groups are 
reprinting and distributing the material. In a presentation July 27, 1983, 
Secretary Heckler announced the expansion of the nationwide AIDS hotline from 
three to eight lines. Information will be available on a 24-hour basis. 
Currently 8,000-10,000 calls are received per day. On May 24, 1983, I issued 
a press release to clarify the hazard of AIDS and the status of Public Health 
Service efforts in combating the AIDS problem. We have issued press releases 
on all PHS AIDS activities as they occur. As evidence of her concern and 
compassion. Secretary Heckler has visited with AIDS patients at the NIH 
Clinical Center and has written to all Department employees asking them to 



305 



continue to donate blood. This was done to demonstrate the Importance of 
Aialntaining an adequate blood supply and to dispel rumors that there is a risk 
of getting AIDS when donating blood. We are also working with Union groups to 
produce educational materials aimed at specific groups - health care workers, 
paramedics, correctional personnel, morticians and others. 

I shall now present the PHS operational plan which we have followed in 
attempting to solve the AIDS problem. 
Centers for Disease Control (CDC ) 

The activities of the CDC fall into four major areas: surveillance, 
epidemiologic studies, laboratory investigations, and dissemination of 
information. 

The goal of surveillance is to describe accurately the scope of the AIDS 
epidemic by time, place, and person, and requires the use of a standard case 
definition and report form. The CDC surveillance system is largely based on 
the voluntary submission of case reports from State and local health 
departments and individual physicians. Additional cases are obtained through 
reviews of requests for pentamidine, a drug used to treat Pneumocystis 
pneumonia and only available through the CDC. The case reports from these 
sources are the basis of all national AIDS statistics. Within the past 6 
months, surveillance has been strengthened by a CDC funded cooperative 
agreement in New York City and by the assignment of federal public health 
advisors to assist health departments in New York City, Miami, Los Angeles, 
and San Francisco. The CDC is working closely with the Conference of State 
and Territorial Epidemiologists to improve the surveillance of AIDS 
nationwide. As of July 15, 1983, 16 States have mandated reporting of AIDS 
cases, and an additional 22 have officially proposed such a requirement. In 



306 



addition, a special surveniance project to determine the incidence of AIDS in 
hemophilia patients was completed in collaboration with the National 
Hemophilia Foundation. 

Using epidemiologic studies, the CDC has sought to determine risk factors 
and modes of transmission for AIDS. A national case-control study of AIDS in 
homosexual men was conducted in the fall of 1981. This study established that 
homosexual men with large numbers of sexual partners are at increased risk for 
AIDS. Further evidence of sexual transmission was found in 1982 from the 
investigation of a cluster of homosexual male AIDS patients who were linked by 
sexual contact. Other investigations in 1982 found evidence for AIDS in 
individuals with hemophilia who had received clotting factor concentrates and, 
possibly, additional persons who had received other blood products. 
Investigations now being implemented include a study of risk factors for AIDS 
in Haitians living in Miami and New York City, a study of a cohort of almost 
7,000 homosexual men in San Francisco, and a study of the risk of AIDS in 
health care workers. AIDS patients not belonging to known risk groups 
continue to be investigated as they are reported. 

Laboratory work at the CDC has been in the areas of irranunology and 
infectious diseases. Through collaboration with scientists inside and outside 
the Public Health Service, CDC investigators have helped characterize the 
specific immune defect caused by AIDS and have studied the immune status of 
apparently healthy homosexual men and patients with hemophilia. In our search 
for the causative agent of AIDS, we have used advanced techniques of virology 
and molecular biology. CDC scientists are collaborating with investigators at 



307 



the National Cancer Institute and the Harvard School of Public Health to 
examine the possible role of a retrovirus, identical or similar to the human 
T-cell leukemia virus, in causing AIDS. Animal studies into the cause of AIDS 
are in progress. 

The CDC has disseminated timely information to medical and public health 
personnel and the general public about the AIDS problem. Between June 1981 
and July 1983, 21 AIDS-related articles have appeared in the CDC Morbidity and 
Mortality Weekly Report (MMWR). Included were articles on general prevention 
recommendations (March 1983) and safety precautions for health care workers 
(November 1982). These MMWR articles on AIDS have regularly been described by 
the print and electronic media to the general public. CDC investigators have 
also published articles in scientific journals, spoken at medical and 
scientific meetings and public forums, and been available to the media. 

CDC 4s in frequent daily contact with local and State health officials, 
representatives of concerned groups and health professionals. 
National Institutes of Health (NIH) 

The NIH is supporting a wide range of AIDS research by its own scientists 
and by university and private investigators. Collaborative as well as 
independent research efforts have been undertaken both intramural ly and 
extramurally by the National Cancer Institute (NCI), National Institute of 
Allergy and Infectious Diseases (NIAID), National Heart, Lung, and Blood 
Institute (NHLBI), National Institute of Neurological and Communicative 
Disorders and Stroke (NINCDS), departments of the NIH Clinical Center, and 
other components of the NIH. 



308 



NIH Intramural scientists have been involved collaboratively in treating 
patients at the Clinical Center since 1981. Thus far, 69 AIDS patients have 
been treated at the hospital, of whom 15 have died. Currently 54 patients are 
under treatment, 12 of these are inpatients. The other 42 cases are being 
treated as outpatients, or as inpatients whose stay may be only 1 to 2 days in 
length. 

Extramural activities have included the issuance of two Requests for 
Applications (RFAs) jointly sponsored or funded by the NCI and the NIAID. The 
most recent of these RFAs was issued in May 1983, with an application deadline 
of August 1 and awards to be made early in fiscal year 1984. 

The purpose of this recent RFA, entitled "Infectious Etiology of Acquired 
Immune Deficiency Syndrome (AIDS) and Kaposi's Sarcoma," is to encourage 
studies on the search for the isolation and the characterization of the 
biological agent(s) which may be the primary causative factor{s) in AIDS and 
Kaposi's sarcoma. 

■ Examples of the types of studies that might be appropriate include: 

- Direct in vivo and in vitro efforts at isolation, identification, and 
characterization of the causative biological agent; 

- Analysis of human tissue with appropriate tests indicative of the 
presence, state of integration, and location of viral or pro-viral 
DNA, or some other infectious forms; 

- Recognition and identification of marker antigens of pathognomonic 
significance; 

- Cytogenetic analysis for chromosomal changes that relate to disease 
induction; and 

- In vitro search for direct morphological transformation and/or 
cytopathology of appropriate target cells. 



309 



NatlonaT Institute of Allergy and Infectious Diseases (NIAID) 
Intramural Research 

There are more than 30 Individual research projects within the Intramural 
laboratories of NIAID which directly relate to AIDS. These Involve studies on 
the nature of the Immune deficiency, development of methods for early 
detection of disease. Isolation of possible etiologic agents, and attempts to 
transmit the disease to nonhuman primates and therapeutic trials. 

Research on therapeutic procedures Includes trials of Immune Interferon 
and Interleukin 2 for their effectiveness In treating AIDS. In addition, 
studies are underway for the use of bone marrow transplants for the 
reconstltutlon of the cellular Inmune system of AIDS patients. Several 
studies are aimed at understanding the nature of the Immune dysfunction, 
including investigations on the activation and Immunoregulation of B 
lymphocyte function and characterization of the nature of the defect in 
purified populations of T4 lymphocytes. The latter project also involves 
attempts to clone helper T-cells and isolate the agent Involved In AIDS. 
Studies are also in progress of the alterations In the reticuloendothelial 
system. The process and nature of immune complexes in AIDS patients are under 
investigation. Plasma from AIDS patients is being studied for Its effect on 
various cell functions. 

Projects related to the development of early detection methods include 
the serologic evaluation of blood from patients for the detection of Beta-2 
microglobulins and studies to determine If B cell activation is a marker of 
disease. 

Many intramural projects Involve attempts to identify a possible 
etiologic agent for AIDS. Studies are underway using various DNA 



310 



hybridization. Isolation and serologic techniques to Identify microbial 
agents. Emphasis is being placed on various agents including retroviruses, 
adenoviruses, cytomegalovirus, Epstein-Barr virus, various parvoviruses, 
rickettsia and chlamydia. In addition, a search Is being made for the 
presence of slow viruses in brains of AIDS patients who develop dementia. 
Attempts are being made to transmit AIDS to nonhuman primates; in addition, 
the imnunologic changes seen in primates following injection of AIDS 
infectious tissues and blood are being studied. 

The NIAID Intramural Program has recently awarded a contract to the New 
York Blood Center to obtain specimens of blood, semen, feces, and saliva from 
several groups of individuals considered at high risk of acquiring AIDS, 
These specimens will be obtained regularly and stored. If AIDS develops in 
any of the study participants, these specimens will provide valuable material 
for many of the projects concerned with determining the etiologic agent, 
developing detection methods, and studying modes of disease transmission. 
These specimens will be particularly valuable as they will have been 
collected at the time the AIDS infection was first transmitted, a time which 
may precede diagnosis by months or even years. 
Extramural Programs 

Four applications have been funded in response to the National Cancer 
Institute (NCI) Request for Application (RFA) on AIDS research that was Issued 
in August 1982. The NIAID Advisory Council was polled by telephone several 
weeks prior to the May 1983 meeting in order to expedite the funding of these 
applications. The applications include studies on the following: 

- potential drug treatments for Pneumocystis car in 11 pneumonia in an 
animal model; 



311 



- the prevalence and transmission of cryptosporidiosis, a recently 
identified parasitic disease that can cause severe and potentially 
fatal diarrhea in the immunosuppressed patients; 

- the development of opportunistic infections in infants born to mothers 
who were sexual partners of AIDS patients; possible routes of 
transmission of AIDS 'among contacts of adult heterosexual patients; and 

- evaluation of chemotherapeutic and naturally occurring substances for 
the treatment and prevention of AIDS, as well as the study of 
immunologic defects in AIDS patients and the possible relationship of 
cytomegalovirus to the cause of AIDS. 

Other funds support research project grants not submitted in response to 
the RFA, including the effects of cytomegalovirus on cell-mediated immunity, 
plus AIDS projects at ongoing NIAID Sexually Transmitted Disease Centers and 
Centers for Interdisciplinary Research on Immunologic Diseases which include: 
a study to define the interrelationship between the "AIDS prodrome wasting 
syndrome" and fully developed AIDS in case control and cohort studies; a study 
of life style and other factors influencing occurrence of AIDS in homosexual ly 
active young males, including association of sexual practices with altered 
helper/suppressor T-cell ratios; and a study analyzing T-lymphocytes of AIDS 
patients by molecular hybridization with specific DNA probes in order to 
detect and quantitate the number of genome copies of cytomegalovirus and 
herpes simplex virus type II DNA in these lymphocytes. 

On May 9, 1983, NIAID issued a Request for Proposal (RFP) ("Study of the 
Natural History of Acquired Immune Deficiency Syndrome (AIDS) in Homosexual 
Men") which will support a prospective study with the following specific 
objectives: 



312 



— To prospectively observe and study the natural history of the disease 
in enough persons in high risK groups who are not known to be infected 
at the outset to yield a number of cases of AIDS sufficient for 
meaningful estimates of risk; 

— To build a repository, as a national resource for specimens and data 
from men to traverse the entire course from well to ill; it would 
permit testing of hypotheses about etiologic factors; and 

— To complement similar smaller, but less well standardized, follow-up 
studies performed in different places and times. 

Twenty-five proposals in response to the RFP were received by July 8, 
1983. All were reviewed, and at least four of these proposals are expected to 
be funded by the end of October 1983. 
National Cancer Institute (NCI ) 
Intramural Research 

NCI intramural activities' related to AIDS can be divided into research 
which is concerned with AIDS and peripheral research which examines the immune 
system from a broader perspective. Both human studies and animal models are 
needed in this endeavor. Intramural research which is directly related to 
human AIDS is divided into clinical and laboratory efforts. 

Clinical Efforts 

- AIDS patients who have developed Kaposi's sarcoma are being treated 
through a variety of approaches in the NCI's Clinical Oncology Program. 

- Treatment protocols of Kaposi's sarcoma are composed of chemotherapy 
regimens which involve combinations of cytotoxic drugs. 

- Kaposi's sarcoma skin lesions - a prominent feature of the disease - 
are being treated through radiotherapy procedures which involve Phase 



313 



I and II trials of total skin electron beam therapy. 

- Experimental treatment of Kaposi's sarcoma is being attempted with 
human lymphoblastoid interferon - a substance that may reduce tumors 
while not further depressing the patient's immune system. 

- In an effort to restore the patient's diminished immune system, the 
NCI is attempting to ''use purified human T-cell growth factor 
(interleukin 2) with AIDS patients. 

Laboratory Efforts 

- A major focus of the NCI's efforts is to determine the possible 
causative role of human T-cell leukemia virus (HTLV) in AIDS. Active 
projects involve cellular biology, immunology, and molecular cloning 
of the many viral isolates obtained thus far. 

- Mechanisms of the immune dysfunction found in AIDS are being studied 
at the genetic, viral, and pharmacologic levels; HTLV appears to be 
the only known infectious agent which is detected at a high degree of 
frequency in AIDS patients, and a lesser degree in lymphadenopathy 
syndrome, and at a very low frequency in matched control homosexual 
populations. 

Other 

- NCI epidemiologists are conducting epidemiological studies of 
immunological profiles of healthy homosexual men and profiles of 
hemophiliacs with symptoms, as well as individuals with AIDS or 
members of population groups at risk of developing AIDS. NCI staff 
have studied individuals at risk in New York, Washington, D.C., and in 

Denmark. An analysis of the epidemiology of HTLV incidence in Japan 
and the Caribbean is being correlated with the distribution of HTLV in 
lymphodenopathy and AIDS patients. 



314 



Intramural AIDS Task Force 

Because of the unique expertise In HTLV within the NCI, the Institute 
established an in-house task force composed of a basic science, clinical, 
and extramural staff. The intramural task force is responsible for 
coordinating research efforts within the NCI and for maintaining close 
collaboration with other interested national and international 
scientists. Specific collaboration on the molecular biology of HTLV 
involving nucleic acid and protein sequencing and synthesis is going on. 
Recently the task force has expanded its efforts to include the Frederick 
Cancer Research Facility (FCRF), research and support contracts. These 
units have the unique ability and expertise in virus and lymphokine 
production as well as a ready scale-up capacity. 
ExtramuraJ Programs 

The NCI has called upon a variety of resources in an effort to respond 
quickly to AIDS. Mechanisms of response and support include grant, 
cooperative agreement and contract awards, the development of specialized 
Requests for Applications (RFAs), special workshops, the establishment of an 
extramural working group, and presentations to and discussions with the NCI's 
advisory bodies, i.e.. Boards of Scientific Advisors and the National Cancer 
Advisory Board (NCAB). 

Workshops and Presentations 

- In September of 1981, shortly after the CDC first learned about AIDS, 
the NCI sponsored a workshop on AIDS. NCI-supported scientists along 
with NCI staff came together to discuss preliminary research leads and 
discuss a coordinated course of research activities. 



315 



- A workshop also was developed for the NCI's Division of Cancer 
Treatment's Board of Scientific Advisors. 

- The NCI alerted the NCAB to the growing problem of AIDS early on and 
has discussed its research directions at every subsequent board 
meeting. Investigators from the CDC have discussed their findings with 
the Board. The NCAB is closely following research related to AIDS and 
has agreed to an accelerated review process for AIDS applications. 

- Three meetings have taken place recently. One of these brought 
together all the cooperative agreement grantees. Two meetings involved 
a combination of NCI AIDS intramural task force staff and outside 
federal and university scientists active in the area of retrovirus and 
AIDS. 

Extramural Awards 

In an' effort to respond quickly to this new public health problem, the 

NCI awarded supplemental funding in September 1982 to encourage AIDS 

research. 

An RFA entitled "Studies of Acquired Immunodeficiency Syndrome" was 

developed, and cooperative agreement awards have been and continue to be 

made as a result of this announcement. Studies being funded include: 

• Epidemiologic studies designed to identify possible etiologic 
factors in affected patients or in individuals with prodromal conditions; 

• Basic research projects on etiology and pathophysiology. These 
include studies in such areas as immunology, microbiology, virology, 
toxicology, etc., and include studies of AIDS, Kaposi's sarcoma, and 
allied conditions; and 

• Innovative clinical treatment and prevention research protocols 
which are linked to hypotheses of etiology. 



316 



- - To date, nine cooperative agreements have been funded, and the NCI wiTl 

continue to fund approved applications from the RFA. The review process 

that led up to these and subsequent awards was substantially shortened at 

all stages, with the NCAB participating in a mail ballot rather than wait 

for a regular board meeting. 

The NCI continues to encourage investigator-initiated grant applications 

and expedites the review of any applications related to AIDS that are 

received. 

Contracts also have been employed to help in the AIDS research effort. 

In general, contracts are used to support laboratory and epidemiologic 

studies. 

Extramural Working Group 

The NCI has formed an extramural working group which consists of all 
NCI-funded grantees and includes NCI and other NIH staff with participation 
from the CDC. This group meets regularly to discuss ongoing research and 
share preliminary findings. This mechanism allows for a fast exchange of 
information among investigators and obviates the need to wait for published 
results. The NCI felt this type of information exchange would be essential 
for a continued quick response to this public health emergency. Members of 
the working group are included in the NCI's intramural task force enhance 
coordination of research efforts. 
National Heart, Lung, and Blood Institute (NHLBI) 

NHLBI is primarily involved in two aspects of the AIDS problem: (1) in 
regard to its responsibility for hemorrhagic disorders, such as the 
hemophilias, NHLBI is concerned with the care and treatment of these patients 
with blood and blood products; and (2) in regard to blood and blood products, 
the Institute has a major concern for the safety of these products. It is 



317 



under the latter rubric, blood safety, that efforts to identify carriers of 
AIDS by means of various screening tests are being carried out. 

Intramural Research 

NHLBI has established an intra-agency agreement with the CDC to 

investigate possible changes in the immune system in patients with 

hemophilia, sickle cell anemia, and Cooley's anemia, all of whom receive 

numerous infusions of blood and blood products. Approximately 200 

patients from New York are being studied. 

NHLBI also has an intra-agency agreement with the Clinical Center, NIH, 

which will attempt to transmit AIDS to chimpanzees using plasma obtained 

from patients with AIDS. If AIDS is caused by a transmissible agent, 

using material from active cases and injecting it into nonhuman primates 

offers a good chance for identifying the agent. 

NHLBI sponsored a conference on the association of blood and 

blood-product use with AIDS, March 15, 1983. The conference was attended 

by 35 scientists, clinicians, and administrators to develop research 

recommendations for the Institute. 

An intramural research project involves study of the immune system of 

sickle cell anemia and Cooley's anemia patients who receive numerous 

infusions of blood. Specific components on the surface of certain white 

cells are being investigated as possible markers for changes in the 

immune system of patients with AIDS. 

With the co-sponsorship of the NCI and the NIAID, the NHLBI will hold a 

NIH Research Workshop on the Epidemiology of AIDS in September 1983. 

This meeting will focus on the relationship of various factors that 

determine the frequency and distribution of AIDS in the community. 



26-097 O— 83 21 



318 



A meeting of the Inter-Agency Technical Committee on Heart, Blood Vessel, 
Lung, and Blood Diseases and Resources focused on the current state of 
knowledge regarding AIDS was held on May 4, 1983. 
Extramural Programs 

On July 15, 1983, the NHLBI published an RFA to encourage investigators 
to develop tests that can be used to rapidly, simply, and specifically 
identify carriers of AIDS. Presently there is no laboratory test to 
identify individuals who carry the disorder. 

The NHLBI will soon issue an RFP to solicit contract proposals for a 
large scale prospective study on the association of blood and blood 
products to AIDS. The RFP will be issued by the middle of August. The 
work conducted under the contract will: (1) examine alterations in 
iimune function among patients who receive many blood transfusions to 
determine whether these alterations bear any relationship to the 
development of AIDS; (2) compare post-transfusion changes among 
populations receiving many blood transfusions (patients with sickle cell 
anemia. Thalassemia, and those undergoing treatment for trauma) with the 
incidence of the alterations among control groups; and (3) establish a 
blood serum and blood cell repository that can be used in future research 
efforts in AIDS. 

NHLBI is supporting a research project grant to study, prospectively, 
changes in the immune system in patients with hemophilia. This project 
will provide useful information concerning the natural history of immune 
disturbances observed in hemophiliacs. 

Researchers in two program project grants are studying the possible link 
between blood product use and AIDS. These studies focus on genetic and 
inmunologic factors that may contribute to the development of AIDS. 



319 



NationaT Institute of Neurological and Communicative Disorders and Stroke 
(NINCDS) 

The NINCDS is involved in a number of intramural projects, including 
investigations on the interaction between viruses and the host imnune system 
to examine mechanisms of protection as well as disease production in the case 
of acute or chronic infections of the cerebral nervous system. The NINCDS is 
also involved in a collaborative effort with the California Primate Center to 
study Simian Acquired Immune Deficiency Syndrome (SAIDS), a disease in Macaque 
monkeys similar to humans. This disease has been transmitted in the 
laboratory, but the etiological agent has not been identified. In addition. 
Institute staff are seeing patients admitted by the NCI and the NIAID at the 
NIH to study the deterioration of neurological functions in patients with AIDS. 
Food and Drug Administration (FDA) 

FDA's efforts have been focused in two areas: 1) the safety of blood and 
blood products with regard to infectious agents transmissible through these 
products; and 2) research directed toward elucidating the etiology of AIDS. 
With respect to the first of these efforts, the work of the FDA has centered 
on issues of blood collection, processing, and use while coordinating with 
various blood service organizations. FDA has issued guidelines to blood 
collection centers on the prevention of AIDS through the screening of donors 
at increased risk. FDA is also working with blood product manufacturers in an 
evaluation of methods which might be applied to clotting factor concentrates 
to increase the safety of their use. In collaboration with scientists at the 
CDC, 200 separate lots of clotting factor concentrates prepared by the four 
major U.S. manufacturers were assayed for virus contamination. The results of 
these studies were negative. 



320 



Research has also been performed in the FDA regarding the etiology, 
pathogenesis and treatment of AIDS. Studies pertaining to the etiology of 
AIDS have been directed towards studying the significance of herpes viruses in 
these patients. Through these studies it has been found that two herpes 
viruses, cytomegalovirus and Epstein-Barr virus, are extremely common in AIDS 
patients and are frequently associated with Kaposi's sarcoma. These results 
are the basis for current efforts to determine whether the associations are in 
any way indicative of an etiological role for one or both of these viruses. 

Studies of the pathogenesis of AIDS have been designed to determine what 
the abnormality of the immune system is that causes patients to be susceptible 
to opportunistic infections. These studies have demonstrated that AIDS 
patients are susceptible to opportunistic infections, at least in part if not 
totally, as a result of an arrest in maturation of immune cells. This defect 
can be corrected vn vitro by treating cells from AIDS patients with a 
lymphokine, interleukin 2. The cause of this maturation arrest is under 
investigation. 

Studies of treatment of AIDS patients have involved close collaboration 
in clinical studies being performed at the NIH. The FDA has done substantial 
testing to evaluate the effects of experimental treatments on the immune 
systems of the patients. 

The future directions of these research programs will be to continue to 
pursue the leads that have been developed in each of these studies. These 
studies will be extended to individuals in high risk groups. In addition, as 
clues are developed from basic research on the etiology and immunology, 
laboratory tests which detect abnormalities which are specific for AIDS will 
be pursued as possible screening tests. Plans are under development now to 
begin experimental application of one such test. 



321 



FDA has made a special effort to maintain a broad dialogue with the 
sc1e"nt1f1c and manufacturing community and with the various organizations of 
the blood service complex. To this end a series of workshops have been held 
Involving the Blood and Blood Products Advisory Committee, the Office of 
Biologies staff, outside expe^t consultants, the manufacturers, and 
representatives of the American National Red Cross, the Council of Community 
Blood Centers, the American Association of Blood Banks, the American Blood 
Resources Association, and the National Hemophilia Foundation. 

At Its July 19 meeting, FDA's Blood Products Advisory Committee discussed 
the safety of plasma derivatives. This is of concern because hemophiliac 
patients require treatment with a product, antihemophiliac factor (AHF), 
derived from plasma which is pooled from thousands of donors. However, I 
would emphasize that the risk of transmitting AIDS to an individual 
hemophiliac from a special lot of AHF is very small, if it exists at all. The 
Committee recommended that no regulatory requirements regarding the recall or 
destruction of lots of AHF, which may contain plasma from an AIDS donor, be 
developed but that any cases that are identified be examined individually. In 
reaching such a conclusion, a number of variables must be considered such as: 
the degree of specificity of the diagnosis, the time of onset of symptoms in 
relation to the time of donation, the potential effect upon the immediate 
supply of AHF and the long-term production of this essential plasma 
derivative. Let me emphasize that the health of the Individual hemophiliac 
patient will be a continuing concern for the PHS. 

Additionally, through these collaborative efforts, progress In developing 
new procedures for increasing the safety of clotting factor concentrates have 
been accelerated. One such product is currently available and others are at a 
late stage of development. This ongoing cooperative effort will continue to 



322 



monitor the nation's blood supply In attempts to Insure maximum safety and at 
the same time maintain adequate supplies of blood and blood products. 
Alcohol. Drug, and Mental Health Administration (ADAMHA) 

Seventeen percent of all AIDS cases are intravenous (IV) drug abusers. 
ADAMHA' s National Institute for Drug Abuse (NIDA) is undertaking several 
investigations to study AIDS in drug abusers. A technical review to examine 
issues surrounding risk factors related to drug abuse was convened on July 25, 
1983. Epidemiological investigations will include case-control studies of IV 
drug abusers, studies of children of IV drug abusers, and studies of potential 
synergy between homosexual lifestyle and drug abuse in predisposing to AIDS. 
Laboratory investigators will study the effect of abused drugs on the immune 
system. In addition, NIDA is developing programs for staff education at drug 
treatment centers and assisting with distribution of PHS materials. 

The National Institute of Mental Health (NIMH) held a research planning 
workshop on August 1, 1983 to address the mental health aspects of AIDS. 
Research will be encouraged in several areas: (1) the effects of stress on the 
imnune system; (2) the psychological effects of AIDS on high risk groups; (3) 
how to meet the psychological and emotional needs of AIDS patients; (4) 
anxiety in health care workers; and (5) the role of community and family in 
providing emotional support. A workshop to address the emotional concerns and 
support needs of AIDS patients, relatives, and health care providers will be 
held on August 3, 1983. 
Non-governmental Organizations 

It is important to recognize that a nunfcer of non-governmental 
organizations have worked with Public Health Service agencies in planning 
studies of AIDS or in making recommendations for AIDS prevention. These 
organizations include, among others: 



323 



1. Public and private medical centers providing care for AIDS patients 
and/or conducting scientific studies of AIDS. 

2. City, county, and State Health Departments; 

3. The Conference of State and Territorial Epidemiologists; 

4. The Association of S^ate and Territorial Health Officers; 

5. The American Association of Physicians for Human Rights^ 

6. The National Gay Task Force; 

7. The Association of Haitian Physicians Abroad; 

8. The National Hemophilia Foundation; 

9. The American Red Cross; 

10. The American Association of Blood Banks; 

11. The Council of Community Blood Centers; 

12. The American Blood Commission 

13. The National Funeral Directors Association; 

14. American Federation of State, County, and Municipal Employees; 

15. The American Public Health Association. 

Mr. Chairman, Let me assure you that we are making every effort to 
cooperate and assist you in meeting the subcommittee's responsibilities In a 
manner which does not violate the confidence placed in us by patients, 
physicians, and State and local health officials. 

I appreciate the opportunity to present the PHS story on our AIDS efforts 
to the members of this subcommittee. A continuing commitment of all our 
energies is required and pledged to eliminate the suffering and death caused 
by this problem. 

My colleagues and I shall be glad to respond to any questions which you 
or other members of the subcommittee may have. 

Thank you. 



324 



bO 




325 



Figure 2 

CASES OF ACQUIRED 
IMMUNODEFICIENCY SYNDROME (AIDS) 
BY QUARTER OF REPORT 

SECOND QUARTER 1981 -SECOND QUARTER 1983 

UNITED STATES 



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326 






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327 

Mr. Weiss. Thank you very much, Dr. Brandt. 

Let me state at the outset, before any questions are asked, that I 
have been impressed with the high regard with which you and 
your colleagues are held by people in the profession and the com- 
munities in which you have dealt, even through this particular 
crisis and epidemic. So I want you to understand that none of our 
questions are directed at you personally by way of questioning or 
attacking your professional capacity or professional integrity. This 
goes for all of you. 

At the outset, let me address the issue that I had raised before 
you began to testify, because we have a limited time for a hearing 
today. We will have other hearings later on. But I do want to try to 
resolve the open question of access. I understand that we have had 
some developments within the last day or so. 

Let me address you, Dr. Foege, in this regard. I know of your 
concern for the confidentiality of patients' names and information 
about them. We share that. And indeed we have tried to make 
clear from the very beginning that we not only are not interested 
in seeing those names ourselves, but we question whether in fact 
CDC ought to have those names. I gather that you are now moving 
in that direction from the testimony that was just given; that is, 
you are not requesting the names to be sent on to CDC. 

We have, within the last week, forwarded to you a proposal 
whereby it would be absolutely clear, no matter what the rights of 
the subcommittee are— as a matter of constitutional and legal 
right, we have the right to see files in their entirety, including 
names— that none of our staff and none of the members of the sub- 
committee would get to see any of the names of AIDS patients. 
There was an eight-step procedure that v/e submitted to you. 

I wonder if you would tell us what your reaction is to that pro- 
posal and how we will proceed as we go on to the question of confi- 
dentiality? 

Dr. Foege. Thank you, Mr. Chairman. 

I think the proposal made last week is a great step forward. I 
think it is unfortunate that we have had this difference of opinion. 
With your permission, I think it might be useful if we would in- 
clude for the record the correspondence that we have had between 
you and myself and other members of the Department on this. 

Mr. Weiss. Without objection, that correspondence will in fact be 
included in the record. 

[The information follows:] 



328 



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■ArwOHD J. McCWTH. M.T. 



NINETY-EIGHTH CONGRESS 

(Tonfiress of the lanitd States 

H^oBse of "Rtprtfientatttits 

INTERGOVERNMENTAL RELATIONS AND 
HUMAN RESOURCES SUBCOMMITTEE 

OfTHE 

COMMITTEE ON GOVERNMENT OPERATIONS 

MYBURN HOUSE OFFICE BUILDING, ROOM B-372 

WASHINGTON. DC. 20616 

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May 12. 1983 



The Honorable Margaret M. Heckler 

Secretary 

Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, D.C. 20201 

Dear Madam Secretary: 

I am writing to request your assistance in obtaining certain information 
from the Center for Disease Control (CDC) in Atlanta, Georgia. 

Specifically, I am requesting that the CDC provide to subcommittee staff 
full access to all Center personnel and to all documentation reposited in the 
files of the Center. 

As you may be aware, a member of my subconmittee staff is currently 
visiting the CDC in Atlanta for the purpose of gathering information and 
documentation pertaining to the Center's research into the cause and treatment 
of Acquired Inmuno- Deficiency Syndrome (AIDS). As she has encountered great 
difficulty in obtaining the cooperation of CDC manaqement, I would very much 
appreciate your informing the agency of its responsibility and obligation to 
the Congress in responding to oversight inquiry. 

I trust that future visits by staff will be accommodated in appropriate 
and responsive fashion. 

Thank you for your cooperation in this matter. 

Since 



\IW^'^ 



%bV45 




TED WEISS 
Chairman 



pCID: Um^^^ 

DATE: -MA Y 1 8 B 65---- 

Correapondenco Unit, OD 
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329 



EFO/ TELECOPiEP -4??; 13- 5-33; ; J: ^ Tm; . ; -. bl^aS^io:a 2 

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The Honorable Ted Weiss 

Chairman, Intergovernmental Relations 
and Human Resources Subcommittee 
of the Committee on Government Operations 

House of Representatives 

Washington, D.C. 20515 






m ! 2 m 



Dear Mr. Chairman: 

Thank you for your letter requesting assistance in 
obtaining certain information from the Centers for Disease 
Control. I want to assure you that we will cooperate fully 
with your staff in providing them access to appropriate 
personnel of CDC and to any documents that may be necessary 
or relevant to your oversight inquiry. 

It is my intent to affirm and support, as we have in 
the past, policies and procedures which will provide all of 
the information you desire and request in a manner that will 
be the least disruptive to the i.r.portant ongoing work and 
mission of the Department. 

I'm sure you will agree that an orderly and organized 
process will facilitate the exchange of information between 
oar staffs. 

With respect to the individuals whom your staff desires 
to interview, we will need some advance notice from you of 
the names of the employees so that schedules may be arra.nced 
in a mutually convenient m.anner and tPcy may be apprised of 
their responsibility to cooperate with your staff and of 
their individual rights. If your staff is going to be 
visiting an office at a particular time, advance notice of 
that visit will enable us to rearrange schedules accordingly 
in order to make available all of those individuals whom you 
desire to interview. 

With respect to documents which you may wish to review 
and/or duplicate, I would ask that you give us advance 
notice of the subject matter of your inquiry and the category 
of docu[r,ents or files to which you would like to have access 
in order that we can arrange to have those files available 
and to determine that they contain no information (such as 



330 






trade secrets, patient specific material or grand jury 
information) to which access would be restricted by law. 

I am sure you appreciate the need for the fair and 
orderly process I have outlined. In this way, we can both 
be assured that we are carrying out our respective responsi- 
bilities in a manner that is productive, meets the needs of 
the Subcommittee, minimizes disruption of agency work and is 
in the public interest. 

I have asked the Assistant Secretary for Legislation, 
Mr. Thomas R. Donnelly, Jr. to assist you in making 
particular arrangements as outlined above. If you or your 
staff have particular problems that are not addressed above, 
Mr. Donnelly will be pleased to meet with you or your staff 
to work out any necessary arrangements. 



Sincerely, 



Margaret M. Heckler 
Secretary 



331 






donaress of the Biu'tal jBmtB 

• liloiisc of TviprcsnitQtltJCB 

IMTERCOVERNMrWTAL ^lnA•^0^;S AND 
• HUMAN RESOURCES SUBCOMMfTTEE 

■rCXIMMnTEE ON GOVERNMENT OPERATIONS ' * 
' >*rMjiM Mcun or?KX MQAHa aooM a-ST* 

. .poSZIS-ZMi 



Hay 17, 1963 






The Hon'orable Margaret M. HecXJ-er 

Secretary 

Department of Health and tiusum Services ' 

?Q0. ^pdependence Avenue, S.W. 

Nasbingcon, D.C. 20201 

Dear 'Madaa Secretary; , '.• 

Thank you for your letter of May 12. I appreciate your 
zeiteratiog the Department ' b intention to cooperate fully with the 
fiubconmittee in the performance of its oversight responsibilities and 
•^••.^•v-• your desire to maintain the orderly and orgemized process of 
. x>r*:JjfdQht investigations which this stibcommittee has traditionally 
foJ'lcwed. 

- In the past the subcommittee has enjoyed excellent cooperation 
from the Department and its personnel. Until recently, we have 
experienced little difficulty in obtaining the information necessary 
for the subcommittee's worX. Unfortunately, t"his has not been the 
expsrience over the past few weeks, when our investigators have 
encountered tactics at the Food and Drug Administration, the Center 
for Disease Control, and numerous institutes within NIH. which have 
seriously impeded our oversight work.' ..;... 

With respect t>o the proposed procedure set forth in your letter,". 
2 appreciate the need to minimize disruption of agency, personnel, 
while at the same time assuring complete and independent congressional 
r«viet/ of I>epartjnent programs and regulatory activities. In the past. 
It has been our. practice to give advance notice of our visits whenever 
possible, ajid I welcome your essistance in the scheduling of those 
interviews. However, there are circumstances which do not lend 
themselves to pre-notif ication when our investigators must contact 
specific personnel directly to arrange appointments at . a mutually . 
convenient time. To the best of my knowledge, no case of unreasonable 
interference was ever brought to the attention of this subcommittee 
while following that procedure. • " 



332 



1 also*. appreci«tF your Butjocptior. that Hcoartinent staff bi 
upprisea of ■ their responsibility to cooperatr with Congressiona) 
Investigatort and of their rights. As in the past, we will continue to 
«ppris« executive personnel that the Rules of the House perxait then to 
have personal 'legal counsel in attendance during interviews or during 
-appearances before the subcoFnaittce to give . testinony. "The potential 
chiUiag effect, however, of permitting the , presence of other thixd 
parties during oversight interviews is one which we cannot condone. 

With respect to our review of agency files, it has been and will 
continue to-be the practice of this ci^coronittee to apprise various 
■ get>cies-of our intention to visit and/i^vicv> files whenever possible, 
as well as to advise them of the . general\ subject matter of «ur 
inquiry. However, l am sure that yo>J- wQiJi^ag"* ^»t it would be 
inappropriate to require advance notice of the specific matter or 
docvuaents as a pre-condition to the Department's release of the files 
■or that materials purportedly containing trade secrets, patient 
specific material or grand jury information be^xpunged prior to our 
exanination. \^ 



!• iooX forward to your continuing cooperation. 




TED WEISS 
Chairman 



333 



TED WEISS. NY. CHAIRMAN 
^HN CONVpfS. JR. MICR 

Ii:S"J'J£;''nr" NINETY-EIGHTH CONGRESS 

EOOLPHUS TOWNS. H-T. 
BEN EtORElCK ALA. 



' IM.FRED *. [A^ McCANOLESSf CAl 



Congress of the flnited States 

IfloDSE Of TEUpresentatftiEB 

INTERGOVERNMENTAL RELATIONS AND 

HUMAN RESOURCES SUBCOMMITTEE 

Of THE 

COMMITTEE ON GOVERNMENT OPERATIONS 

RAYBURN HOUSE OFFICE BUILDING. ROOM B-372 

WASHINGTON. DC. 205 IS 

1202) 22»-264S 



May 17, 1983 



Dr. William H. Foege 77 

Director _^ 

Centers for Disease Control .~_ 

1600 Clifton Road, N.E. 
Atlanta, Georgia 30333 ^ 

Dear Dr. Foege: 

I am extremely surprised and distressed to learn of the serious lack of 
cooperation afforded my staff last week by CDC personnel. 

As you know, Ms. Susan Steinmetz traveled to Atlanta at my direction to 
gather information and documentation pertaining to the CDC's research into 
the cause, treatment, and prevention of Acquired Immune Deficiency Syndrome. 
This followed numerous telephone communications the previous week to advise 
you and other agency personnel of our planned activities. Unfortunately, 
the continued refusal of CDC officials to grant my staff full access to 
personnel and documentation left me no alternative but to recall Ms. Steinmetz 
to Washington without having obtained the information sought by this 
subcommittee. 

I am particularly disturbed by the procedures announced by Mr. Elvin Hilyer 
and Mr. James Bloom which were clearly designed to limit Congressional access_ 
to information and to interfere with the subcommittee's right and responsibility 
to conduct thorough oversight review of the agency's activities. Specifically, 
there is no justification whatsoever for: (1) CDC executive officers prohibiting 
direct contact with CDC personnel regarding arranging appointments for interviews 
that were mutually convenient; (2) restricting the questions prepared by 
subcommittee investigators; (3) prohibiting CDC employees from discussing plans, 
policies, or budget requests under development; and (4) requiring my staff to 
interview public employees only under the surveillance of management supervisors. 

It is particular outrageous that Mr. Hilyer attempted to instruct my 
staff that her visit would be terminated on May 11 and that agency personnel 
(/ould no longer be made available to speak to her. 



n /I6V3, 



CDC ID: 

DATE: MAY 18^ 

Correspondenoo Unit , OD 
Hxt . 3322 



26-097 O— 83 22 



334 



The agency's blatant attempt to disrupt Congressional oversight work 
is a very serious matter. I sincerely hope that it will not be repeated. 



Sincen 




TED WEISS 
Chairman 



335 



XEROX TELECOPIER 495; iO- 6-83; -i:07Fn 



623632.96;« 2 



Kwon s WALxn. r*. 

ALnVO A. |AU McCAMDlCK Calf 

^„, M^i'JVl'" NINFTV-EIGHTH CONGRESS 

iDCA^usTovwi.wT o/iu sent 

.«» _ . - _ »• - ■. . /mim--.. .J /--T--_^i^^ copies to: Foege 



Conigrefis of the Bnited States 

ftonse of KeprtBoitfltftjes 



Watson 

Hilyer 

Bloom 

Dowdle 

Hicks 



INTERGOVERNMENTAL hEUVTIONS AND 

HUMAN RESOURCES SUBCOMMITTU 

Of TKI 

COMMITTIE ON GOVERNMENT OPt!lATIONS Berreth 

(taiBuRN MOUSE oracetuiixiNO.iicout-sii Matthews 

WASHlNOTON.o.c. W)»1S Crittenden 



ooa u>-iM< 



Pickelsimer 
CvJfni ps 



June 10, 1983 ^^1=° distributed in 

HHS and PHS by Franc ie 
dePeyster) 

Dr. Williair H. Foege 

Director 

Centers for Disease Control 

1600 Clifton Road, N,E. 

Atlanta, Georgia 30333 

Dear Dr. Foege: 

The subcoiraiir.tee is continuing an inquiry into Federal p .y, 
coordination, and preparedness for health emergencies, especially in 
light of oui experience in the current AIDS crisis. As part of this 
investigation, I am wiiting to request that you subjiit to the 
subcommittee the following information and doc'jmentation: 

1. All r.emoranda or letters and/or other documents which have teen 
circulated at CDC regarding the access of Congressional subcommittees to 
files and ptrsonrpl undor your direction, whether or not these documents 
were created by ycu or others in the Department. 

2. A listing, by cateaory, sub-category and type, cf all files and 
docj.-nentation pertai.iing to AID? research and surveillance projects 
which are maintained by your office and by each of the offices and 
laboratories within the CDC. 

3. For each of the fiscal years 1981, 1982, 1983, and 
1984-projected, please provide: 

(a) a listing, by name and position, of all CDC personnel 
assign. at CDC h-»adqu3rters and in the field (designate location) to 
work en AIDS . search and surveillance (specify whether full or 
part-time) ; and 

(b) for each of these individuals, a scatenent of his/her 
function and responsibilities prior to and after having been assigned to 
AID.S work. 

4. For each of the fis'^al year;: 1281, 1^82, 1983, and 
1984-projected, please provide: 



336 



EtFO. 'ELECOPIEP 495; 10- 6--8~; 4:CI9Fn 



32363296; S 3 



(a) a .listing, and dates of initiation and termination, of all 
AIDS activities at CDC facilities (designate location); and 

(b) the proposed and actual funding for each of these 
activities. Please provide all supporting documentation. 

5. For each of the fiscal years 1931, 1982, 1983, and 
1984-pro]ecced, please provide: 

(a) a listing of each of the ATDS-related projects that has 
been proposed, but disapproved; 

(b) the dates of propocj] and disapproval; 

(c) the reason (s) for disapproval; 

(d) the identity of the proposer. 

Please provide all supporting documentation. 

6. f.-r eich of the fiscal years 1931, 1982, 1983, and 
1984-projectri.', please provide: 

(a) a detailed breakdown of funds and positions transferred 
froir. other CDC/HHS activities (please specify) to AIDS projects within 
CDC; and 

(b) a detailed breakdov/n of hirings of individuals from 
ou' ■■ie of Orc/HHS to specifically work on AIDS projects and the 

. ■ -.s to which these individuals were assigned. 

'. All documents relating to proposed CDC requests for additional 
f ji. iing and positions for AIDS activities. 

■. All docvutients which illustrate CDC's role and involvement in 
<■<.. ai.iiating the response of the Public Health Service to the AIDS 
epidejp.ic. Please include correspondence between CDC and MIH, FDA, and 
the Assistant Secretary for Health, as well as minutes from raeetinos 
whir-h in'/olved CDC and other Federril agencies. 

I would appreciate receiving your resix-nce to this preliniinary 
request, at your earliest convenience, by July 1, 1983. So as to 
facilitate expeditious transri tr.il , please provide the information and 
documentation on an incienental basis. 



Thank you for your coopetatic 




Sincere 

TED WEISS 
Chairman 




337 



, DETAKTMEM (M IILAll H *. IIU V. AN SI li VU i S C)M„r r.i it,,- S-r.rta.v 



Wabhingion, D C 20201 

JUN I 7 1933 

EYES ONLY 

ITie Honorable Ted Weiss 

Chairman, Intergoverrmental Relations and 

Human Resources Subccinmittee 
U.S. House of Representatives 
Washington, D.C. 20515 

Dear Mr. Chairman: 

■Jliis is in response to your letters of May 17 and June 10 to Di . William H. 
Foege, Director of the Centers for Disease Control (CDC), regarding the visit 
to CDC of Ms. Susan Steinmetz of your staff, and your subsfx^uent written 
request for information and documentation. 

As we were in the process of responding to your earlier letter to Dr. Foege, 
we received the latter one requesting canprchens ive information on Acquired 
Iimune Deficiency Syndrone (AICS) fran CDC. Agency personnel, including 
scientists involved in research on AICB, aix; currently undertaking the 
extensive effort necessary to canpile the documentation that you have 
requested. I must point out that the prijnary responsibility of these CDC 
personnel is, and should continue to be, to canbat AIC6. We will begin to 
submit materials as rapidly as possible. However, we c.^nncit meet the July 1 
deadline with all materials witlout inortiiivitely diverting CDC staff, 
currently worising on laboratory and other investigations on Air8, fron their 
primary duties. 1 am sure you will agree that this would not In in the public 
interest. 

We sincerely rtaret that durirg her visit, Ms. Steirrretz sei3Tt-d to perceive 
CDC p-srsonnel ^iS unresponsive to her needs as a Subconmittee investigator. 
To my knowledge, CDC made ri-unerous efforts to accoiunodate Ms. Steiimetz's 
schedule. As you may know, these efforts were cunplicated by previous CDC 
staff ccranitnents related to a full day scientific mi-eting on AIIJ6 and blood 
products previously arrarqed for Tliuisday, May 12. 

As ycu know, Secn3tary Heckler's policier. ruganlirg the DepdrLmunt's 
procedures for cooperating with Congrt?ssional oversight investigations have 
been set forth in her letter to you of May 12. ax: and all its personnel are 
prepared to carry out the spirit and intt?nt ot the Serixjtary's letter. 

The objectives of this Depart-m;nt and your SuU-cinni ttee are tJic same. I 
ttnroughly retjret any misumieriU aivHt«)S wtiich in.iy fxir.t rtrjartliiYj your staff's 
visit to CDC. Our d.'sire is to work exit .my sucIj ii.isuixieislandings so that 
you can obtain tlie information you need to carry cmI your Coiyrcssional 
responsibilities in a manner which is lo.-ist di;;iui)l ive of the Dejia rtment ' s 
ongoing work. 

SiiK-.TT-ly, 




_Tl'KJiw:r. R. [Vjnnclly, 
Assist.int SL-cretary f(Jr-Jjet)islation 



338 

JUN 2 4 ?983 



The Honorable Ted Weiss 

Chairman, Subcommittee on Intergovernmental 

Relations and Human Resources, Committee 

on Government Operations 
House of Representatives 
Washington, D. C. 20515 

Dear Mr. Weiss: 

The information on Acquired Immune Deficiency Syndrome (AIDS) requested 
in your letter of June 10 is being forwarded in incremental packages as 
the information and supporting documentation are collected. The packages 
will be tabbed in reference to the questions in your letter. 

The enclosed package contains tabbed material as follows: 

Question 1. - complete information 
Question 7. - complete information 
Question 8. - partial information, remainder later. 

Subsequent increments will be supplied in like fashion. 



§J<&*c /^ "Z^^- 



/ - y 

William H. Foege , M.D. (/ 

Assistant Surgeon General 
Director 



Enclosure 



339 



JUL 1 1983 



The Honorable Ted Weiss 

Chairman, Subcommittee on Intergovernmental 

Relations and Human Resources 
Committee on Government Operations 
House of Representatives 
Washington, D. C. 20515 

Dear Mr. Weiss: 

The enclosed material is the second incremental package providing the 
Information on Acquired Immune Deficiency Syndrome (AIDS) requested In your 
letter of June 10. 

The enclosed package contains tabbed material as follows: 

Question 6. (b) - complete information 

Question 8. - additional information, completing this item. 

The previous package contained tabbed materials as follows: 

Question 1. - complete information 
Question 7. - complete information 
Question 8. - partial information. 

Subsequent increments will be supplied in like fashion. 

Sincerely yours, - ^^V^ 

William H. Foege , M. D. 
Assistant Surgeon General 
Director 

Enclosure 



340 



JKL 3 s J9e3 



The Honorable Ted Weiss 

Chairman, Subcommittee on Intergovernmental 

Relations and Human Resources 
Committee on Government Operations 
House of Representatives 
Washington, D. C. 20515 

Dear Mr. Weiss: 

The enclosed material is the third and final Incremental package providing the 
Information on Acquired Immune Deficiency Syndrome (AIDS) requested in your 
letter of June 10. 

The enclosed package contains tabbed material as follows: 

Question 2. - complete information 

Question 3. - complete information 

Question l*. - complete information 

Question 5. - complete information 

Question 6(a). - complete information. 

Sincerely yours, 

William H. Foege , M.D. / v^ '"'^ 

Assistant Surgeon General ^ 

Director 

Enclosure 



341 



Question 1. All memoranda or letters and/or other documents which have been circulated 
at CDC regarding the access of Congressional subcommittees to files and 
personnel under your direction, whether or not these documents were created 
by you or others in the Department. 

Included in this Tab are the following documents: 

May 24, 1983 Memo from Dr. Brandt to PHS Agency Heads, OASH Staff Office Directors 
Re: Congressional Inquiries 

May 20, 1983 Memo from Anthony L. Itteilag to OPDIV Executive Officers 

Re: OMB Clearance of Budgetary Information for Congressional 
Committees 

May 17, 1983 Letter from Mr. Weiss to Secretary Heckler 

May 12, 1983 Letter from Secretary Heckler to Mr. Weiss 

April 29, 1983 Memo from Secretary Heckler to Operating Divisions/Staff Divisions, 
Regional Directors 
Re: Congressional Activities 

November 4, 1982 Memo from President Reagan to Heads of Executive Departments and 
Agencies 

Re: Procedures Governing Responses to Congressional Requests for 
Information 



July 2 8, 1982 General Administration Manual Issuance 

Re: Disclosure of Individually Identified Records to the Congress 

June 15, 1982 Correspondence Handbook, Chapter CDC 1.2 & Illustrations 
Re: Congressional and Other Controlled Correspondence 

March 13, 1980 Memo with attachment from Dr. Foege to Directors, 
Bureaus/Institutes/Of f ices 
Re: Communications with Congressmen 

February 28, 1980 Memo with attachment from Charles Miller to PHS Agency Heads, Deputy 
Assistant Secretaries for Health, Staff Office Directors 
Re: Congressional Correspondence 



August 30, 19 79 



June 22, 1979 



March 15, 1979 



Memo with attachment from Dr. Foege to All Bureau/Institute/Office 

Directors 

Re: Communications with Members of Congress and Staff 

Memo with attachment from Dr. Foege to All CDC Supervisors (to Branch 

level) 

Re: Communications on New Legislation 

Memo with attachment from Dr. Foege to All Bureau/Office/Institute 

Directors 

Re: Congressional Contacts 



342 



Question 2. A listing, by category, sub-category and type, of all files and 

documentation pertaining to AIDS research and surveillance 
projects which are maintained by your office and by each of the 
offices and laboratories within the CDC. 

Included in this Tab is the following document: 

A listing of all files maintained at CDC which pertain to AIDS. 



343 



Question 3. For each of the fiscal years 1981, 1982, 1983, and 

198^projected, please provide: 

(a) a listing, by name and position, of all CDC personnel 
assigned at CDC headquarters and in the field 
(designate location) to work on AIDS research and 
surveillance (specify whether full or part-time); and 

(b) for each of these individuals, a statement of his/her 
function and responsibilities prior to and after 
having been assigned to AIDS work. 



Included in this Tab is the following document: 

A listing of CDC Employees Assigned to Work on Aids 
Fiscal Years 81, 82, 83 , & 84 



344 



Question A. For each of the fiscal years 1981, 1982, 1983, and 
1984-projected, please provide: 

(a) a listing, and dates of Initiation and termination, of 
all AIDS activities at CDC facilities (designate 
location); and 

(b) the proposed and actual funding for each of these 
activities. Please provide all supporting 
documentation. 

Included in this Tab are the following documents: 

Summary of AIDS Activities 
Supporting Documentation 

Epidemiological Investigations 

Surveillance 

Laboratory Investigations* 

Technology Transfer/Information Dissemination 
Bibliography of CDC Published and Proposed Journal Articles 



♦Description of nitrite inhalent study by NIOSH not 
included. This information will be supplied when available. 



345 



Question 5. For each of the fiscal years 1981, 1982, 1983, and 

1984-proJected, please provide: 

(a) a listing of each of the AIDS-related projects that 
has been proposed, but disapproved; 

(b) the dates of proposal and disapproval; 

(c) the reason(s) for disapproval; 

(d) the identity of the proposer. 

Please provide all supporting documentations. 
Included in this Tab are the following documents: 
Statement concerning projects 



346 



Question 6(a). For each of the fiscal years 1981, 1982, 1983, and 

198A^projected, please provide: 

(a) a detailed breakdovm of funds and positions 

transferred from other CDC/HHS activities (please 
specify) to AIDS projects within CDC. 

Included in this Tab are the following documents: 

Comments concerning listing 

Listing of positions and funds transferred from other 

CDC/HHS activities to AIDS projects within CDC 
Backup Information on CDC AIDS Resources 



347 



Question 6. For each of the fiscal years 1981, 1982, 1983, and 
1984-projected, please provide: 

(b) a detailed breakdown of hirings of individuals from outside of 
CDC/HHS to specifically work on AIDS projects and the projects 
to which these individuals were assigned. 

Included in this Tab are the following documents: 

Explanation of listing 

Listing of individuals hired outside of CDC/HHS to 
specifically work on AIDS projects 



348 



Question 7. All documents relating to proposed CDC requests for additional 
funding and positions for AIDS activities. 

Included In this TAB are the following documents: 

Centers for Disease Control - AID Funding History 

Centers for Disease Control - Legionnaires' Disease, Toxic Shock 
Syndrome, and Acquired Immune Deficiency Syndrome (obligations in 
thousands) 

Supplemental Appropriations Bill, 1982 

DHHS PHS AIDS - Effect of House and Senate Action, FY 1983 
Supplemental Request (HF, SC) June 1983 

May 20, 1983 Letter from Thomas R. Donnelly to Mr. Gar Kaganowlch 

with attachments - Amendment to House Full Committee Print of 

FY 1983 Supplemental Appropriation Bill and Draft Report Language 

May 18, 1983 Letter from Dr. Brandt to Mr. Natcher with Current 
Level Funding, May 12 Update on AIDS, and Report on AIDS 
Additional FY 1983 Activities (in priority order) 
Note: Dr. Brandt's letter and attachments were inserted in the 
Congressional Record - House, May 25, 1983, beginning on page 
H 3337. 

May 13, 1983 Memo with attachments from Dr. Foege to Assistant 
Secretary for Health, Re: Additional AIDS Resource Needs 

May 13, 1983 Memo with attachments from Dr. Brandt to Assistant 
Secretary for Management and Budget, Re: Additional AIDS 
Resource Needs 

May 9, 1983 letter from Mr. Natcher to Dr. Brandt 

FY 1984 0MB Submission 

FY 1984 Appropriation Hearing - Dr. Foege' s Opening Statement 

FY 1984 Congressional Submission 

Information from Supporting Data Book-FY 1984 Congressional 
Hearings 

1984 Budget Appeal 

Report to Congress, 6/15/83 

Questions and Answers Provided at the Request of the House 
Appropriation Subcommittee as a Result of the FY 1984 
Appropriation Hearings 

Questions and Answers Provided at the Request of the Senate 
Appropriation Subcommittee as a Result of the FY 1984 
Appropriation Hearings 



349 



Que s too & 



All documents which Illustrate CDC's role and involvement 
in coordinating the response of the Public Health Service 
to the AIDS epidemic. Please include correspondence 
between CDC and NIH, FDA, and the Assistant Secretary for 
Health, as well as minutes from meetings which involved CDC 
and other Federal agencies. 



Included in this Tab are the following documents: 



June 17, 19 83 

June 15, 1983 
June 10, 1983 

June 8, 1983 
June 2, 19 83 

May 2 7, 1983 

May 2 7, 1983 
May 23, 1983 

May 17, 1983 

May 16, 19 83 



Memo from the Assistant Secretary for Health to Director 
CDC, Director NIH, and Commissioner, FDA 
Re: Coordinating AIDS Policy 

Progress Report to the House Appropriations Committee on 
Acquired Immune Deficiency Syndrome 

Memo from Chairperson, Public Health Service (PHS) 
Executive Committee on Acquired Immune Deficiency Syndrome 
(AIDS) to the Assistant Secretary for Health 
Re: Biweekly Report on the Status of AIDS - INFORMATION 

Memo from the Assistant Secretary for Health to Assistant 
Director for Public Health Practice, CDC/PHS 
Re: Congressional Report on AIDS 

Memo from Assistant Director for Public Health Practice, 
CDC, to the Assistant Secretary for Health 
Re: Proposed Advisory Committee on Acquired Immune 
Deficiency Syndrome (AIDS) 

Memo from Assistant Director for Public Health Practice, 
CDC, to Members of the PHS Executive Committee on AIDS 
Re: Committee Communications 

PHS AIDS Executive Committee 

Memo from the Assistant Secretary for Health to PHS Agency 
Heads, OASH Staff Office Directors 
Re: AIDS Correspondence 

Memo from Chairman , PHS AIDS Executive Committee to 

Committee Members 

Re: PHS AIDS Executive Committee Meeting 

Memo from the Assistant Secretary for Health to Agency 
Heads, PHS, Members, PHS AIDS Executive Committee 
Re: PHS Acquired Immune Deficiency Syndrome (AIDS) 
Executive Committee 



May 16, 19 83 Memo from the Assistant Secretary for Health to Members, 

PHS AIDS Executive Committee 

Re: Formal Constitution of PHS Acquired Immune Deficiency 
Syndrome (AIDS) Executive Committee 

February 25, 1983 Memo from the Director, Centers for Disease Control to the 
Assistant Secrerary for Health 

Re: Prevention of the Acquired Immune Deficiency Syndrome 
(AIDS)— ACTION 



26-097 O— 83 23 



350 



Included In this Tab are the following documents: 

June 27, 1983 Memo from the Chairperson, PHS Executive Committee on AIDS, 
to Assistant Secretary for Health, PHS (with attachments). 
Re: Biweekly Report on the Status of Aids - INFORMATION 

June 17, 1983 Memo from Assistant Secretary for Health to Agency Heads 
and OASH Staff Offices. 
Re: Acquired Immune Deficiency Syndrome 

June 16, 1983 Note to Dr. Jeffrey Koplan from Assistant Secretary for 
Health. 
Re: Memo of June 9 - briefing on AIDS 

June 15, 1983 Note to Dr. Koplan from Shellie Lengel, OPA , PHS. 
Re: AIDS fact sheet dated June 13, 1983 

June 14, 1983 Note to Dr. Koplan, Chairman, PHS Executive Committee on 
AIDS, from Shellie Lengel. 
Re: Draft leaflet for the public on AIDS 

June 13, 1983 Memo from Assistant Secretary for Health to Director, NIK. 
Re: NHLBI Proposal to Form AIDS Expert Panel 

June 6, 1983 Memo from Chairperson, PHS Executive Committee on AIDS, to 
Assistant Secretary for Healt*". 
Re: Biweekly Report on the Status of AIDS - INFORMATION 

June 1, 1983 Note to Dr. Koplan from JimBuchan, Office of Public 
Affairs, PHS. 

Re: Dr. Koplan' s participation on AIDS in the U.S. 
Conference of Mayors on June 12, 1983, in Denver 

May 2 7, 1983 Memo from ADAMHA AIDS Representative to Chairman, PHS AIDS 
Executive Committee. 
Re: ADAMHA AIDS Activities 

May 24, 1983 Statement on AIDS by Edward N. Brandt, Jr. , M.D. (for 
release). 

May 23, 1983 Memo from Scientific Director, NIAID, NIH, to Dr. Robert 
Gordon , Chairman , NIH Working Group on AIDS. 
Re: AIDS Research Projects in the Intramural Programs of 
NIH Institutes 

May 19, 1983 Report prepared by the Food and Drug Administration: 
"Current Research and Future Needs for Study of the 
Acquired Immunodeficiency Syndrome (AIDS)." 



351 



May 19, 1983 Weekly report from FDA on AIDS activities - to Chairperson 

of PHS AIDS Executive Committee. 

May 16, 1983 Memo from Director, National Institute of Allergy and 

Infectious Diseases, NIH, to Assistant Secretary for Health. 
Re: Summary of trip to Haiti on May 3-10, 1983, in regard 
to AIDS - INFORMATION 

May 12, 1983 Agenda and Attendees for Meeting of Outside Consultants on 

the Association of AIDS with Blood and Blood Products 

April 21, 1983 Memo from Dr. John Killen, Head, Medicine Section, CIB , 

CTEP, OCT, NCI, NIH, to NIH staff. 
Re: AIDS Extramural Working Group Meeting, May 6, 1983 

March Ik, 1983 Memo from Director, Office of Biologies, National Center 

for Drugs and Biologies, FDA, to All Licensed Manufacturers 

of Plasma Derivatives. 

Re: Source Material Used to Manufacture Certain Plasma 

Derivatives 

with enclosures listed below: 

Memo from Director, Office of Biologies, FDA, to All 
Establishments Collecting Human Blood for Transfusion. 
Re: Recommendations to Decrease the Risk of 
Transmitting AIDS from Blood Donors 

Memo from Director, Office of Biologies, FDA, to All 

Establishments Collecting Source Plasma (Human) , (plus 

attachments). 

Re: Recommendations to Decrease the Risk of 

Transmitting AIDS from Plasma Donors 

February Ik, 1983 Memo from Director, AIDS Activity 

Re: Meeting with Dr. Coutinho & Professional Eascoal 
The Netherlands - 3/22/83 w/2/11/83 Itr from Dr. Coutinho 

January 12, 1983 Memo from Director, CDC, to Assistant Secretary for Health, 
PHS. 

Re: Summary Report on Workgroup to Identify Opportunities 
for Prevention of AIDS, January k, 1983 

August 17, 1982 Memo from Assistant Secretary for Health to Director, CDC. 

Re: Report of PHS Committee on AIDS 

August 6, 1982 Memo from Director, CDC, to Assistant Secretary for Health. 

Re: Open Meeting of the PHS Committee on Opportunistic 
Infections in Patients with Hemophilia, July 27, 1982, 
Washington, D. C. (summary report attachment) 



352 



The accompanying table lists positions and funds transferred from other 
CDC/HHS activities to AIDS projects within CDC in FY 1981, 1982, and 1983. 

In fiscal year 1984, it is anticipated that all personnel assigned full time 
to AIDS work will be permanently assigned to the AIDS project group in CID. 

The activities of many other personnel who work in laboratory-related 
positions (as evidenced in the response to question 3) were redirected to 
place some priority on conducting laboratory investigations of AIDS. However, 
these personnel were not transferred from their original organization to the 
AIDS Activity. 



353 



JUL 1 2 1983 



•oDo^^.cSr.njT' NINETY-EIGHTH CONGRESS 

■IN f KDUiCn. ALA 



Congress of the lani'terl States 



tionsE of "RtpTE^mtariDES 

INTERGOVERNMENTAL RELATIONS AND 

HUMAN RESOURCES SUBCOMMITTEE 

Of THI 

COMMITTIE ON GOVERNMENT OPERATIONS 

RAYBURN HOUSE OFFICE BUILDING. ROOU 8-472 

WASHINGTON. DC. ZOtlt 

poa 2»-»4i 



July 5. 1983 



{M-:^^^^^^^'^^!^ 



Dr. Will iam H. Foege 

Director 

Centers for Disease Control 

16C0 Clifton Road, N.E. 

Atlanta, Georgia 30333 

Dear Dr. Foege: 

This is to inform you that Mr. Martin Landry of the General Accounting 
Office has been assigned to the staff of the Intergovernmental Relations 
and Human Resources Subcommittee of the Committee on Government Operations. 
He will assist the subcaTimittee in its continuing inquiry into the Federal 
response to the AIDS epidemic and other health emergencies. Mr. Landry has 
my full authorization to conduct investigations on behalf of this sub- 
committee. I would very much appreciate your cooperation in providing 
Mr. Landry with full access to any and all information, documentation, and 
personnel requested. 

Thank you for your cooperation in this matter. 

Sincerely,(\ 

TED WEISS 
Chairman 



354 



urNtOA lAtiUcCAMOLCSS. CAUr 



jruiNriiNtim j« I 



'*""" " '"" """ NINETY-EIGHTH CONGRESS 



• oOOf MmJLAV «1A 



Congress of the Bnited States 

IFioiiBE of 'RepraentanDts 

INTERGOVERNMENTAL RELATIONS AND 

HUMAN RESOURCES SUBCOMMITTEE 

Of in* 

COMMITTEE ON GOVERNMENT OPERATIONS 

RAYeURN HOUSE OFFICE BUILOING. ROOM 6-373 

WASHINGTON, D C 20S 1 B 

|}Oa}l>-lB«t 



July J"-, l-)fii 



William 11. focgo , M.P. 

Director 

Centers for Di:;o.Tse Coiitrnl 

1600 Clifton Road, N.E. 

Atlanta, Georgia 30333 

Dear Dr. Foege: "^ 

It again boi.-cnios i-.uccss.iry fu rci liT.iLe the subcoitinittee'E 
position regarding tlie conduct of our oversight investigation at CDC. 
It is unfortunate that you arc continuing to delay the subconunittec 's 
performance of its investigation into thf Federal response to the AIDE 
crisis. 

First, .^-s ■. o'.i know, there is no legal basis Lor denying the 
subcoruuttec acct.'SS to filer. mniiiLjined at I he Center based either on 
grounds cf "budget information, poli.-y formation, or patient 
confidentiality." With regard to patient information, I reiterate 
that the subconnittee has no interest or intention of removing the 
names of patients from CDC files. However, wo must maintain the 
ability to reviev; those files directly. I am enclosing a proposed 
procedure for file review and duplication for the purpose of this 
investigation only. 

As I advi^uti * he .'ccretaiy in my May 17 letter, the Department 
should feel free Co advise all oi its .employees of their right to have 
personal legal counsel in atLfiidanro during interviews or during 
appearani;es bcf.ire the subcommittee to qivi' testimony, and of their 
right to decline interviews with congri.'s;,iona) investigators, should 
they so choose. Of course, the subcominitt ■<• would thoi. have the right 
to call such f^ersons before the sub.-'-mmittee in Washington. 
Permitting the piesi'ice of othoi third partii';. durinti ir:ferviews could 
hiivo .I'seriour. ehillii i effect on coni^ros-^irn.il '>ver:^i.jht . 



C-i 



.JUL 18 1983 . 

o'f>H " 



355 



I want to jssure you that th.i subc^'inmitcee's inquiry seeks to 
determine that CDC and other Federal agencies are receiving adequate 
Federal resources, in a coordinated manner, to meet this public health 
crisis, and that the confidentiality or 
maintained. 



AIDE victims is being 



The subcommittee does not intend to allow your lack of 
cooperation, without legal or other justification, to interfere with 
this critical oversight work. 




TED WEISS 
Chan man 



Enclosure 



356 



tlU: RliVIDW/DUPI.ICATION AT CLiC 



1. Subcommittee staff is to be pt-rmittod to retrieve files from 
wherever they are usually reposited (as long as there is no 
interference or interruption of CDC business) . 

2. Staff will tab (paper clip) the materials sought for 
duplication in increments (f ile-by-f lie) tor duplication — two 
copies — one for the suljcommittei;! and one for CDC. 

3. Subconimiltoc staff will keep their ci'pii^s cf documents in a 
loclc-file cabinet provided by CDC while CDC personnel review its 
identical copies for patient names. 

4. Those documents in whii;h CDC finds patient names will be 
duplicated (one copy) and CDC will rctiact (blot out) the patient nnmes 
from this third copy. 

5. CDC will provide the redacted copies to subcommittee staff 
and will pull (under subcommittee supervision) the unredacted 
duplicates from the subcommittee staff's file cabinet for separate 
storage in CDC files and for future reference by subcommittee staff 
(should the need arise) . 



357 



TED WtlSS. N V . CHAIftMAN 
JOHN CONYtBS, ja MICK 
SANOERU UVIN MlCK 
■UDDV M«cKAV. FIA 
EOOLPHUS TOWNS, NY 
SEN ERDREICH. AlA 



NINETY-EIGHTH CONGRESS 

Conigress of the Bnited States 

iHoDse of ■ReprcBtntatiDes 

INTERGOVERNMENTAL RELATIONS AND 

HUMAN RESOURCES SUBCOMMITTEE 

Of mt 

COMMITTEE ON GOVERNMENT OPERATIONS 

RAYBUHN HOUSE OFFICE BUILDING. ROOM &-372 

WASHINGTON. D.C. 20616 

(303) }26-2S4g 



nOBERT S WAUCEn fK 
AUREO A lAU McCANOLESS. ( 
LARRY E. CKAIG. IDAHO 



July 15, 19f',3 



William H. Foegc-, M.D. 

Director 

Centers for Disease Control 

1600 Clifton Road, N.E. 

Atlanta, Georyia 30333 

Dear Dr. Foege: 



I am writing to invite 
subcommittee on August 2 at 
Rayburn House Office Building. 



you to personally appear before tiho 
:00 p.m. in hearing room 2154 of ttrc" 



As you know, the subcommittee has been examining the response of 
the Public Health Service to Acquired Immune Deficiency Syndrome 
(AIDS) . This public hearing will provide an opportunity for the 
subcommittee to review public concerns about AIDS and the Federal 
response to the epidemic. 

Will you please arrange to have 50 copies cf your prepared 
statement delivered to the subcommittee of/ice by no later than the 
close of business on Fr ida^jg^l^pLllSMaj'iy Such advance submission 
is required by the Committee Rules in order to give Members an 
opportunity to study your statement in advance of the hearing. If 
your prepared statement will require more than 10 minutes of oral 
presentation, please be prepared to summarise it in approximately that ' ■ 
time. Your entire statement, regardles."; of its length, will /1o|P^' 
included in the printed hearing record. ^^ 1/^' y^ 

If you are unable to attend, I would appreciate having your 
office notify the subcommittee as soon as possible. A similar 
invitation is being sent to Secretary Heckler by a separate letter. 



I greatly appreciate your cooperation in this important matter. 
If you have any questions concerning tlie hearing, please have your 
staff call Susan Steinmetz at the subcommittee office. 



Sincerely/ 
,1 



TED ^VEISi.: 
Chairman 

II ' / 



<:c--y-- 



-^JJUl^- 



■ "jrvespondenoeUnlt, OD 
h;522 ._ 



r.:-i 



358 



JUL 2 5 1983 



The Honorable Ted Weiss 

Chairman, Subcommittee on Intergovernmental 

Relations and Human Resources 

Committee on Government Operations 
House of Representatives 
Washington, D.C. 20515 

Dear Mr. Weiss: 

I am sorry that you believe we are delaying your investigation of the 
acquired immune deficiency syndrome (AIDS). We are prepared to 
provide you photocopies of all AIDS records with personal identifiers 
removed. While this would require taking people from AIDS activities 
temporarily, thereby interfering with our efforts to solve this des- 
perate problem, we are more than willing to do so in order to assist 
the Subcommittee In their work. The delay in developing a procedure 
has been due to my need to verify specifically whether you are asking 
to see the names of patients with AIDS. 

We indicated to Mr. Landry, the GAO investigator assigned to your 
Committee, that we were prepared to provide all information possible, 
as we have always done with Congressional investigations. When 
Mr. Landry told us in our initial meeting last week that you were 
interested in all information including identifiers and names, I 
thought it necessary to obtain written documentation of your request. 
Also, Mr. Landry indicated that he was instructed not to proceed even 
though we offered to provide AIDS information pending resolution of 
the access issue. 

Your letter, with its attached procedural recommendations, makes it 
clear that you do intend for your staff to see the names of patients 
even though the documents which you would later receive would have the 
names removed. I'm sure you can appreciate the confidentiality 
difficulties Inherent In such a procedure. We are concerned about 
protecting the privacy of all individuals with AIDS, but prominent 
public figures present a special problem if they are identified. It 
would be difficult for any investigator to simply Ignore or forget if 
such an individual were included as a case. 

As you may know, the investigation of AIDS is hampered by the concern 
of patients, physicians, and local health authorities that names given 
to CDC could not be safeguarded. Your request lends substance to that 
concern. We are now working on a procedure which would preclude CDC's 
receipt of names as part of its AIDS surveillance system. All 
documents would be identified by code. Such a procedure will 
obviously extract a price in the efficiency and effectiveness of this 
and subsequent Investigations, but may be the only way to assure 
accurate medical information is collected from patients who are 
concerned about confidentiality and exposure. Your request to see 



359 



names makes it clear that we will have to pay that price in order to 
retain the cooperation of State and local health departments and 
physicians and patients. In summary, our attempts to solve the 
problem of AIDS will be markedly slowed by any requests for patient 
Identification data which will undermine the accuracy or availability 
of future data collection. 

In the meantime, I trust you will agree that there are also moral 
factors involved in this instance that should transcend the legal 
prerogatives of Congress or the Executive Branch. These patients are 
already suffering under a burden of physical disintegration, social 
ostracism, and an unknown future. I cannot add to their burden with 
the possibility that they will be Identified to a Congressional 
office. I sincerely hope you will withdraw your request to see the 
names and identifiers of AIDS patients. 

My staff is already stretched to the limit in attempting to deal with 
this epidemic. I hope we can develop a working procedure to provide 
you with the information you require and at the same time minimize any 
delays this might cause in solving the AIDS problem. 

0MB Circular A-10, prohibits me from complying with your request for 
certain budget information. Once again, let me offer full access to 
all clinical and epidemiological Information short of personal 
Identifications. 

Sincerely yours. 



William H. Foege, M.D. ' X^" 
Assistant Surgeon General ^ 
Director 



360 



no *^9>. N r. CMa:«M** 
jOMM COHltHB JM. U1CH 
AAKOtK U lTVUI MICM. 

•i« VORIIOl ALA 



NlNETY-CtGHTH CONGRESS 

Conigress of the Snitd States 

?unise of Ezprtsentctftts 

INTERGOVERNMENTAL TEWTIONS AND 
HUMAN RESOURCES SUBCOMMITTIE 

c#™« 

COMMITTEE ON GOVERNMENT OPERATIONS 

RArtURN HOUSE OmCI eulLSMa ROOM a-37i 

WASHINOTON. O.C lOSIt 

UOa 22I-2MI 



July 26, 1983 



IIC«HrT t- W*U[IH, FA. 

t^mo K (Mi UcCANOUAl. CAUt. 
LMKT t CftAJO. lOWO 



cc: 

Foege 

Watson 

Bloom 

Hilyer 

Dowdle 

Matthews 

Berreth 

Koplan 

William H. Foege, M.D. Noble 

Director 

Centers for Disease Control 

1600 Clifton Road, N.E. 

Atlanta, Georgia 30333 

Dear Dr. Foege : 

I an in receipt of your letter of July 25, 1983. 

In my letter of July 15, 1983, I stated that "the subcommittee has no 
interest or intention of removing the names of patients from CDC files." 

I am writing once again to emphatically state to you that the subcommittee, 
in performing oversight investigation of the Centers for Disease Control (CDC), 
has no wish, nor does it intend, to collect the names of patients who are 
suffering from acquired immune deficiency syndrome (AIDS) . 

However, this subcommittee is resolved to fulfill its directed respon- 
sibility to conduct thorough and comprehensive oversight investigations into 
the policy, procedure and practice of all Federal agencies and departments 
that fall within the subcommittee's jurisdiction, including the CDC, so as 
to determine program economy, efficiency and effectiveness. Further, it is 
the practice of this subcommittee to conduct such investigations without disrupting 
administration and program of the subject agency or department. 

In order to allay your latest concern expressed in your July 25, 1983, 
letter regarding subcommittee staff "seeing names and identifiers" of RIDS 
patients, especially those of "prominent public figures," I am offering the 
following procedure for subcommittee staff review and duplication of CDC file 
materials:' 

1. During performance of a file search, the subcommittee staff person 
will be accompanied by a CDC staff person whenever necessary. 

2. As the subcommittee staff person selects and retrieves file materials 
(with the CDC staff person present) from wherever they are usually reposited 
(as long as there is no interruption of CDC business) , both the subcommittee 
and CDC staff persons will take the files to a designated room or space nearby. 



361 



3. The CDC staff person, ir. the presence of the subcomraittee staff 
person, will review each of the files to determine if any of the documentation 
therein contain patient naraes and identifiers. Those that do contain patient 
names and identifiers will be removed from each of the files and numbered 
consecutively on the face of each such document by the CDC staff person (in 
the presence of the subcoianittee staff person) . 

4. The balance of the records and documentation remaining in each of the 
files (those not containing patient names and identifiers) will be turned over 
immediately to the subcommittee staff person for review and photocopying (if 
the subcommittee staff person so chooses) . 

5. While the subcommittee staff person is reviewing the documentation 
and records that do not contain patient names and identifiers, the CDC staff 
person will take the consecutively numbered documents and records containing 
patient names and identifiers and photocopy each of then (including all 
attachments thereto) . 

6. The CDC staff person will take the photocopies and blot out all AIDS 
patient names and identifiers. 

7. The CDC staff person will photocopy each of the documents wherein 
AIDS patient names have been blotted out, and will present these copies to 
the subcomraittee staff person for review and retention (if the subcommittee 
staff person so chooses) . 

8. The CDC staff person will return the original and unredacted documents 
and records to the appropriate files, and the CDC will retain the first photo- 
copy of each of the documents and records wherein AIDS patients names were 
blotted out. 

I trust you will find this procedure to be acceptable, as it precludes 
any possibility of subcommittee staff seeing AIDS patient names and identifiers 
and as it requires the services of only one CDC staff person to assist sub- 
committee staff in collecting selected documentation and records in file 
searches that are essential to the subcommittee's investigation. 

Finally, I assume that "budget" issues raised in your July 25 letter will 
be addressed during our meeting next weelc. 



Sincere 




362 

JUL 2 8 1983 



The Honorable Ted Weiss 

Chairman, Subconunittee on Intergovernmental 

Relations and Human Resources 
Committee on Government Operations 
House of Representatives 
Washington, D. C. 20515 

Dear Mr. Weiss: 

The enclosed material is the fourth incremental package providing the 
information on Acquired Immune Deficiency Syndrome (AIDS) requested in your 
letter of June 10. 

The enclosed package contains three items from our National Institute for 
Occupational Safety and Health (NIOSH). These items are to be inserted under 
Questions 2, 3, and i* , as indicated in the note attached to each. 

This package completes the response to your letter of June 10. 

Sincerely yours, ^^^ 



^its^£&^^9^ ^•^' 'Y^'^^'''- 



William H. Foege , M.D 
Assistant Surgeon General 
Director 



''7 



Enclosure 



363 

AUG 1 6 1983 



The Honorable Ted Weiss 

Chairman, Subcommittee on Intergovernmental 

Relations and Human Resources 
Committee on Government Operations 
House of Representatives 
Washington, D.C. 20515 

Dear Mr. Weiss: 

This Is In response to your letter of July 26 outlining a method for your 
subcommittee staff person to review files of the Centers for Disease 
Control without having access to names or other identifiers. Although 
your proposal will require considerable time of a person on our AIDS 
staff to assist with the files. It Is an acceptable procedure to maintain 
confidentiality of personal identifying information in the files, 
including secondary identifiers. 

Sincerely yours. 



^i/i^ 



William H. Foege, M.D. 
Assistant Surgeon General 
Director 




364 

Dr. FoEGE. I think you have made it clear from the beginning 
that you did not want the names of patients who had AIDS. The 
discrepancy has been in the procedure which would have allowed 
your staff to see the names but not have them. I think the proposal 
you made last week corrects that problem, and I think we have 
only minor differences now. 

For instance, I think instead of talking about patient identifiers, 
if we talk about person identifiers, so that if a record includes the 
name of a contact of a case we will not have to provide that name. 
I think with some slight changes that we can now reach an agree- 
ment on how to proceed with the record search. 

Mr. Weiss. Well, without again forgoing any of the constitutional 
prerogatives of the Congress or of this subcommittee, I am sure 
that we can indeed dispose of that as an issue. 

I had occasion yesterday in the course of testimony from some of 
our witnesses to note with some consternation that while you were 
insisting on this unfounded concern about confidentiality as far as 
Congress was involved, you were refusing to discuss the legitimate 
concerns of confidentiality which the affected groups were trying to 
raise with you. I found that sort of perplexing. But in any event, I 
am pleased that we seem to have resolved that issue at this time. 

Now, there are other — would you like to comment on that? 

Dr. FoEGE. I really don't know what that charge is that was 
made yesterday. I would like to know more about it, because I 
think that we have worked extensively with the gay rights groups 
to try to solve questions. So I don't know what that is about. 

Mr. Weiss. Well, they don't believe so. They point to the fact that 
CDC insisted on collecting names; that in some instances the rec- 
ordkeeping and security of those names was so shoddy that names 
were sent by mistake to the New York City Department of Health, 
and so on. 

If you like, I will get more specific information and send it to you 
for your comment. 

Dr. FoEGE. And I would be happy, Mr. Chairman, to talk about 
our security procedures and how we have shared names, under 
what circumstances, if you would like. 

[Material referred to follows:] 




365 



DEPARTMENT OF HEALTH A HUMAN SERVICES Public Health Service 

i _[fl^ Centers for Disease Control 

Memorandum 

D»" July 14, 1983 

From Acting Chief, Surveillance Section, AIDS Activity 

Subject Confidentiality of AIDS surveillance data: Current systems for collection and 
protection of data 

'''° THE RECORD 

This memorandum outlines the legal authorities for collection of AIDS 
surveillance data, protection from unauthorized disclosure of this data under 
the Freedom of Information and Privacy Acts, and the precautions being taken 
by the AIDS Activity to protect sensitive personal information collected 
through the AIDS surveillance system. 

Data collected on the AIDS case report form 

Data requested on the AIDS case report form used for surveillance Includes 
name, date of birth, city and zip code, race/ethnic group, specific medical 
conditions, and risk factors such as sexual orientation (and sex of partners), 
use of drugs, country of family origin, and possible exposures or predisposing 
factors. Information is also asked about laboratory data, hospital where 
treated, and person reporting. 

The following information is not requested: social security number (SSAN), 
street address, telephone number, names or numbers of sexual contacts or 
sexual practices. 

Reportable diseases, surveillance by States, and reporting to CDC 
Each State or local health jurisdiction is responsible for deciding whether 
AIDS (or any other disease or condition) will be reportable and the conditions 
surrounding means of reporting. If a disease is reportable, physicians, and 
frequently hospitals, are responsible for submitting a report regardless of 
the wishes of the patient. This is considered to be a public health 
responsibility and is not a breach of confidentiality or of the 
patient-physician relationship. Consent from the patient is cot required for 
reportable diseases. Reporting from local to State health departments is 
established by State law. Reporting from the State health department to CDC 
Is voluntary and is not mandated by statute or regulation. A State that has 
collected surveillance data about a disease may share that information with 
CDC without informing the patient or obtaining further consent. Further 
release of information by the State, either voluntarily or in response to 
request or subpoena, is governed by applicable State laws and regulations. 

Freedom of Information Act (FOIA) 

FOIA provides for release of records from a Federal government agency to the 
public on request. Specifically exempted from this disclosure, however, are 
"personnel and medical files and similar files the disclosure of which would 
constitute a clearly unwarranted Invasion of personal privacy." 



26-097 O— 83 24 



366 



This provision has been tested In court and has been upheld without disclosure 
of personal or medical Information or general Information that would allow 
Identification of Individuals. Examples of court cases based on this 
principle Include: 

Rural Housing Allowance v. United States Department of Agriculture , 498 
F.2d 73 (D.C. Clr. 1974), 

Wine Hobby USA, Inc. v. United States Internal Revenue Service , 11502 F.2d 
133 (3rd Clr. 1974). 

Rose v. Department of Air Force , 495 F.2d 261 (2nd Clr. 1974). 

Most recently, release by CIX of names of Individuals reported with toxic 
shock syndrome has been denied under court appeal. 

Privacy Act 

The Privacy Act prohibits the government from maintaining secret files about 
Individuals and provides means for an Individual to have access to his/her 
records and to amend incorrect Information in the files. The CDC system of 
files In which records of AIDS patients are maintained is the Epidemiologic 
Studies and Surveillance of Disease Problems system, as described In the 
Federal Register, vol. 47, no. 198, October 13, 1982, pages 45494-96, and 
updated annually. This system provides that "Records nay be disclosed to 
Health Departments and other public health or cooperating medical authorities 
in connection with program evaluations and related collaborative efforts to 
deal more effectively with diseases and conditions of public health 
significance." The system description further specifies the conditions under 
which release of information Is Justified and the precautions to be taken. 

Precautions to protect data at CDC include: "24-hour guard service in 
buildings, locked buildings, locked rooms, personnel screening, locked 
computer rooms and tape vaults, password protection of computerized records, 
limited access to only authorized personnel, i.e., designated researchers, 
epidemiologists, and their clerical staffs. Two or more of these safeguards 
are used for all records covered by this system notice. The particular 
safeguards used are selected as appropriate for the type of records covered by 
each Individual study or specific project. Departmental security guidelines 
will be followed. For computerized records, safeguards are in accordance with 
HHS/ADP System Security Manual, Part 6. The safeguards described for 
nonautomated records are In accordance with Chapter 45-13 in the General 
Administration Manual, and the supplementary PHS chapter. 



367 



Manageme nt of AIDS case report forms at CDC 

States and cities Bubmltting case reports of AIDS to the AIDS Activity have 
been asked to mail the Hat of names and case numbers in a separate envelope 
from the remainder of the case report data. We have requested that all 
envelopes with patient data be clearly addressed to the Surveillance Section, 
AIDS Activity, and be marked "To be opened by addressee only." The envelopes 
with the case reports are opened in Richard M. Selik's office where they are 
processed and stored in locked file cabinets during non-working hours. 
Dr. Selik's office is locked at all times he is not in the office- 
After Dr. Sellk has reviewed, classified, and logged in the cases, the reports 
are hand carried in small batches by an AIDS Activity staff person to Ann 
Rumph, statistical clerk, Statistical Services Branch, DVD, CID. Case reports 
In this office are maintained In a locked file cabinet at all times they are 
not being used directly. After the case data are entered on computer, the 
case report forms are again hand carried by a staff person back to Dr. Selik's 
office where they are filed in the locked file cabinets by case report number. 

Medical epidemiologists and staff members at CDC working on AIDS and with a 
legitimate reason for needing case reports or computer summaries of reports 
have access to the files through Dr. Sellk or another staff person in the 
Surveillance Section authorized to grant such access. Persons using these 
materials are requested to maintain them in strict confidence and to keep them 
in an appropriate locked file or office. 

Managemen t of computerized AIDS case data at CDC 

All computer access to AIDS case data is double password protected. Currently 
only 5 staff people in the Statistical Services Branch, DVD, CID, know the 
password allowing direct access to AIDS case data. All have been informed 
about the need for maintaining confidentiality of patient data and procedures 
for guarding the data against unauthorized access or release. 

Computer records of AIDS surveillance data are maintained on hard disk on the 
ADABASE system. Backup tapes are prepared regularly according to Computer 
Systems Office standard procedures; these tapes are stored in a secure area 
according to standard procedures. Access to CDC's mainframe computer is also 
carefully controlled. 

Ma nagement of computer printouts and tabulations at CDC 
Computer reports of summarized Information without identifying data are 
prepared and distributed to staff members weeUy and at other intervals. A 
single computerized line list of cases is also printed weekly and hand carried 
by authorized Statistical Services Branch personnel directly to Dr. Sellk. 
Under current operating policy, this list is not xeroxed or distributed to 
other staff iembers on a regular basis; authorized persons at CDC working on 
AIDS are able to obtain a copy of the line list as needed for a special 
project from Dr. Sellk. Persons with access to this list are notified of the 
need to keep this and all materials with names or other personal identifiers 
In a locked file or a locked office. 



368 



Computer summflrles of cases reported by Individual States and selected local 
health departments are prepared on a monthly basis by the Statistical Services 
Branch and hand carried to Dr. Sellk's office. Data reports to be mailed back 
to the State and local health departments are prepared by AIDS staff members 
who xerox, collate, and stuff envelopes directly. Printouts with case data 
are stored In a locked office until sealed In envelopes addressed directly to 
the State epidemiologist or designated Indlvual to receive the material; 
envelopes are marked "To be opened by addressee only." Case report material 
without patient names Is sent In a separate envelope from the list of 
patients. 

Case materials, computer reports, and similar Information that may have 
patient Identifying Information but that are no longer needed are stored In a 
box In Dr. Sellk's office until being taken directly for destruction. These 
materials are not discarded through the standard trash disposal system. 

Sharing of AIDS case data with States, public health or medical authorities 
A summary of ways In which AIDS case data (including computer lists or 
summaries of information) has been used or provided to States or other public 
health or medical authorities will be summarized in a separate memorandum 
titled Distribution and Use of AIDS Case List, 



James R. Allen, M.D. 



cc: James W. Curran, M.D. 
Wllmon Rushing 
Richard M. Selik, M.D. 
E. Thomas Starcher 
Dennis J. Bregman, M.S. 

Doc. 0358Q 



»"*^' A 

^ 



369 



DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Centers lor Diicase Control 

Memorandum 



^•" July 19, 1983 

Ffom Director, AIDS Activity 

Subject Confidentiality of AIDS surveillance data: Proposed modification to case 
report system to eliminate collection of patient names 

"f" Director, Center for Infectious Disease 

Within recent months the issue of confidentiality of AIDS surveillance data 
has become Increasingly prominent, despite assurances by AIDS Activity 
|>ersonnel that the names and other Identifying Information about patients Is 
protected from disclosure by a specific exemption of the Freedom of 
Information Act and that data Is collected, handled, and stored according to 
guidelines for the Epidemiologic Studies and Surveillance of Disease Problems 
system of records as required by the Privacy Act. The Centers for Disease 
Control receive and use on a dally basis confidential data abouf patients with 
a variety of diseases and conditions; the Initial reports of patients with 
AIDS were treated with the same precautions accorded other diseases In which 
personal and medical Information Is shared with CDC. As AIDS cases continued 
to be reported, the Information received and used at CDC was separated into 
two classes: (1) Surveillance data, usuolly case reports. from physicians, 
health departments, and others that provided general Information about the 
case; Information Included name, birth date, aexual orientation, and use of 
drugs. (2) Epidemiologic study data, usually specific, detailed. Information 
obtained through special studies or Intensive case Investigations; Informed 
consent from each patient was necessary to obtal-n this detailed Information. 
Measures to protect the security of the AIDS surveillance Information were 
reviewed and tightened In early 1983. 

la spring 1983 a formal AIDS case report form was distributed to State and 
local health departments throughout the country and, with the exception of a 
few cities/counties that had already established active surveillance programs, 
primary responsibility for surveillance was transferred from passive data 
collection at CDC to the State and local health departments. The question 
about whether the name of a patient with AIDS should be Included on the case 
report form was considered In a number of discussions with different groups. 
The primary arguments Included: (a) Detecting and eliminating duplicate 
reports from different reporting Jurisdictions (a real problem with AIDS since 
the disease la prolonged and a patient often is hospitalized in multiple 
cities and States); (b) tracking and updating disease and condition reports on 
patients. Including mortality reports, to more fully and accurately understand 
the natural history of AIDS; (c) correlating laboratory specimens from 
patients and' data from tests performed with case report Information, since 
these often are sent Independently to CDC; (d) conducting special studies that 
require determining through matching whether a given individual has been 
reported as having AIDS (examples Include the study to determine whether 
receipt of hepatitis B vaccine during the vaccine trials increased risk of 
AIDS, and studies to deteralne probability of AIDS being transmitted through 



370 



Mood transfusion). These arguments for collecting Identifying Infoniatlon 
■ eened cogent, and the decision was laade to continue to Include name and date 
of birth on the case report form. This decision was reviewed again by CDC 
program planning personnel and those responsible for clearance; the potential 
for problems was recognized, but the Initial decision was accepted. 

Coincident with the Introduction of the AIDS case report form, several 
Individuals and groups raised questions about confidentiality and the case 
report form, Including the need for name or other Identifying Information, the 
detail of the Information being reported, and the need for Informed consent 
from the patient before a case could be reported. The Importance of studying 
AIDS was affirmed, but there was disagreement about the need for Identifying 
information. Part of the concern resulted from misinformation about data 
being sought on the case report form and misunderstanding about the difference 
between epidemiologic studies and surveillance — and the data collected for 
each. Members of the AIDS Activity met on several occasions with health 
department officials In New York City and Washington, D.C., and with 
representatives from the affected communities to listen to concerns about 
confidentiality, to explain reasons for collecting the names of i'patients, and 
to discuss measures being taken to protect the Identity and confidentiality of 
Individuals. Simultaneous with the surfacing of the concerns about 
confidentiality, we began receiving reports that some physicians treating 
patients with AIDS were refusing to report cases or that they were submitting 
incomplete or Inaccurate information, including aliases or pseudonyms. 

Data collected on the AIDS case report form 

Data currently requested on the AIDS case report form Includes name of 
patient, date of birth, city and county of residence at onset of Illness, 
race/ethnic group, specific medical conditions, and risk factors such as ■ 
•erual orientation (and sex of partners), use of drugs, country of family 
origin, and possible exposures or predisposing factors. Information Is also 
asked about laboratory data, hospital where treated, and person reporting. 

The following information Is not requested on case report forms for 
•uTvelllance: social security number (SSAN), street address, telephone 
number, names or numbers of sexual contacts or sexual practices, specific 
information about drug use patterns. 

Proposed modifications to the AIDS surveillance (ease report) system 
On July 16, 1983, David J. Sencer, H.D., In a dual role as Commissioner of 
Health for New York City and as the representative from a group of health 
coBmlssioners of large cities concerned about AIDS, met with representatives 
of the Surveillance Section, AIDS Activity, to continue discussions about 
confidentiality and concerns about reporting names of AIDS patients. After 
discussing »ltematlve strategies, the following general position was proposed 
that should allow the AIDS Activity to continue to monitor trends and patterns 
in the occurrence of this disease and that Is satisfactory In principle to Dr. 
Sencer. We propose to Implement this system on a trial basis by July 25, 
1983, and then to accept or modify it as soon as we detenalne how well the 
•ystem functions, problems with it, and the reaction of the State and 



Oil 



Territorial epidemiologists and health officers. Target date for a final 
decision la August 31, 1983. with full iDplementation of the system by 
September 30, 1963. 

1. State and local health departments will continue to be the primary focus 
for surveillance of AIDS. To perform this function efficiently, they need 
to continue to obtain names and selected other Identifying Information 
about patients with AIDS. These health departments are urged to take all 
necessary steps to protect the confidentiality of records and information 
In their possession. 

2. Cases of AIDS will continue to be reported voluntarily to the AIDS 
Activity, CDC, through state and local health departments in accord with 
the May 1983 resolution of the Conference of State and Territorial 
Epidemiologists, (a) Given names or Initials of the patient will not be 
reported; the last name (surname) will be encoded using a phonetic 

• ipha-numerlc system that consists of the first letter of tfie surname and 
3 digits. Using this system, it Is impossible to reconstruct a specific 
name from the encoded form. This type of phonetic alpha-numeric system is 
currently in use In other health related areas. Including for management 
of sexually transmitted disease reports, and apparently has been used 
successfully at CDC in the past for special projects, (b) The date of 
birth will be provided, (c) All other Information on the case report form 
will be reported; none of this is patient Identifying Information, (d) If 
a case of AIDS is reported to CDC in which the name is Included, routine 
precautions already In effect will be used to protect that name until It 
can be encoded using the phonetic alpha-numeric system and the name 
deleted. 

3. State and local health departments will continue- to share Information with 
»»fh other c'jout cases of AIDS as necessary. Situations necessitating 
this may Include a resident from one State or area aeeklng treatment In 
another State or area and being reported to health officials In the second 
area, or CDC bringing to the attention of health officials In different 
Jurisdictions that a duplicate case report may exist. 

*• Special Investigations Involving other public health agencies or 

cooperating medical authorities that require matching of lists will be -. 
performed under stringent precautions to protect confidentiality. 
Including submlsEion of a formal protocol with review and approval of the 
protocol by appropriate Institutional review boards (IRBs) and, where 
appropriate, 0MB. Since CDC will not have a list of names of patients 
with AIDS, our Involvement In approved studies may be restricted to 
matching of the phonetic alpha-numeric list with a similar list generated 
by the cooperating group. 

5. Laboratory specimens from AIDS patients submitted to CDC will need to 
continue to be appropriately identified. For speclmena or results that 
need to be linked to case Information In the surveillance file, sufficient 
Information to establish the link will be sought from the appropriate 



372 



physician or health department; no patient name or other Identifying 
Information will be added to the surveillance record system. 

6> Epidemiologic and Intensive case investigations separate from the AIDS 
surveillance system will be conducted as necessary by CDC, usually In 
collaboration with State or local health officials and other cooperating 
nedlcal authorities. The proposed surveillance system for names of 
patients with AIDS may be used for these other Investigations, but this 
nemorandum should not be construed as restricting the design and conduct 
of these other studies. These Investigations generally are Initiated with 
a protocol that has been reviewed and approved through formal clearance 
channels and IRBs Including, where appropriate, expedited clearance 
through OME. In this type of study. Information from Individual patients 
Is collected only after the study has been explained and they have agreed 
voluntary to participate In the Investigation and have signed a consent 
form. 

Proposed changes to the AIDS surveillance data files 

As soon as a final decision Is made about the exact format for name/phonetic 
alpha-numeric code for the AIDS surveillance system, names of all cases of 
AIDS on the surveillance file will be converted to the new system and all 
names as such will be deleted from all computer files. In addition, during 
the trial period of the new^ystem (July-August 1983), proposals for 
aanagement of paper copies of AIDS surveillance forms will be reviewed and a 
decision will be reached about a means to eliminate case names from paper 
records. Possible methods Include obliterating names from the case reports, 
destroying all copies of the paper case report forma, or returning all case 
report forms to the original reporting State or the lasted State of residence 
of the case. A decision about a method will be reached by August 31, 1983; 
work on Implementing this system to modify paper records will be started 
Igmedlately after the decision Is made and will be completed by a target date 
of September 30, 1983. Slmflarly, all existing copies of computer printouts 
of the AIDS case list will be destroyed as soon as the revised system Is 
functioning. 

We would appreciate your comments on our proposed modifications to the AIDS 
surveillance system to assist In protecting patient confidentiality and to 
assure Individuals with this disease and the^lr physicians of our intent to 
■alntaln the privacy of the patients. 



I their physlclar 
James V. Curran, M.D., 




ee: John V. Bennett, H.D. 
WllmoQ Rushing 
James R. Allen, M.D. 
Richard M. Sellk, M.D. 
E. Thonas Starcher 

Doc. 0498Q 



373 



Disclosures made by CDC of Individually Identified AIDS Data 



In certain situations CDC has worked with cooperating public health 
officials and medical authorities, including blood banks, to pursue 
information relating to AIDS cases. Any such disclosures were consistent 
with a routine use under the Privacy Act and were necessary In order to 
carry out epidemiologic investigations of AIDS. 

Disclosures were made pursuant to the Routine Use provision [(Section 
3(b)(3)] of the Privacy Act. 

The published routine use is as follows: 

Records may be disclosed to Health Departments and other public 
health or cooperating medical authorities in connection with program 
evaluations and related collaborative efforts to deal more 
effectively with diseases and conditions of public health 
significance. 

This routine use appears in a notice entitled "Epidemiologic Studies and 
Surveillance of Disease Problems," HHS/CDC/CID, which is published on 
page 45495 of the Federal Register , Volume 47, No. 198, October 13, 1982. 

Comparison of reported AIDS cases with a list of homosexual men who 
received experimental hepatitis B vaccine was crucial due to concerns 
that the vaccine might cause AIDS. Since the earliest vaccine trial was 
conducted among homosexual men at the New York Blood Center, the 
investigation had to be conducted there. Licensing and marketing of the 
vaccine in 1982 gave the investigation added urgency. Although the New 
York Blood Center had an excellent record of maintaining privacy of 
records during its decade of working with the gay community, extra 
precautions were taken. The AIDS list was hand-carried to the Blood 
Center, kept securely locked and hand-carried back to CDC when the 
investigation showed no evidence of the vaccine increasing the risk of 
AIDS. The AIDS list was also checked against the list of vaccine 
recipients In Chicago, Denver, St. Louis, San Francisco and Los Angeles. 
This was personally done by CDC field Public Health Advisors who 
Immediately returned the list to CDC. 

In San Francisco, a case list was provided to Dr. Selma Dritz, the 
physician in the Communicable Disease Division in charge of the AIDS 
surveillance and prevention program to assist in the investigation of 
transfusion related cases in the Bay Area, and to monitor the occurrence 
of AIDS cases in the largest cohort of gay men in the hepatitis B study. 
Only Dr. Drltz had access to the list. She kept it in a locked file 
cabinet in her office at all times she was not using it. The list has 
been transferred to the CDC Public Heath Advisor recently assigned to San 
Francisco to assist with AIDS activities. 

Between February 1982 and June 1983 an updated copy of the national case 
list was provided on approximately four occasions to Dr. David Auerbach, 
CDC field EIS Officer assigned to the Los Angeles County Health 
Department. The list of names was used in epidemiologic investigations 
of AIDS patients who had been sexual partners of each other and In 
studies of transfusion-related AIDS. The only other person to use the 
lists was Ms. Loren Lleb, an epidemiologist employed by the Health 
Department working on AIDS surveillance and epidemiologic 
investigations. The lists were never physically removed from the Health 
Department and were kept in a locked file; outdated lists were 
destroyed. Since Dr. Auerbach has completed his EIS assignment, the list 
has been transferred to the CDC Public Health Advisor recently assigned 
to Los Angeles to assist with AIDS activities. 



374 

Mr. Weiss. Well, whatever additional information you would like 
to have included in the record, we will keep the record of this hear- 
ing open for another 10 days for that purpose, without objection. 

Now, there are some other questions of access that apply. I have 
again been absolutely dumbjfounded by the insistence of CDC, 
under your direction, that there be third parties, management per- 
sonnel, present at discussions between our staff and staff people of 
CDC. 

Now, as a matter of policy, you know or should know that at 
hearings that this subcommittee holds — and, in fact, all the sub- 
committees of this committee — the rules provide the opportunity 
for witnesses to be accompanied by personal legal counsel of their 
own choosing, not because it is a matter of constitutional right but 
because the rules of the House dictate it as a policy decision that is 
appropriate. Our subcommittee has extended it so that if our staff 
people go out to conduct a field investigation or inquiry, we also 
provide the opportunity for people who are to be interviewed, if 
they so request, to have personal legal counsel of their own choos- 
ing present. 

That is a far cry from allowing a Federal agency to have its man- 
agement interpose itself between the staff person to be interviewed 
and our subcommittee staff. That is a chilling and unacceptable 
process. I don't know where you think you have the basis for it. I 
want your comment on having free and unfettered access, with 
prior notification as to time and place, and with no disruption of 
your work. I want your thoughts on having a big brother of the 
agency watching over the interviewing of your staff. 

Dr. FoEGE. I think the request we made, Mr. Chairman, was that 
people who were to be interviewed would be notified of the fact 
that they could have a person in the interview if they cared to. I 
think these were the procedures that Mrs. Heckler put out in her 
letter. 

Mr. Weiss. I am not sure where Mrs. Heckler, who should know 
better, gets that premise, either. As far as we are concerned, we 
have the opportunity to interview people informally or formally. If 
you want it all to be done formally, by subpena, it seems to me 
that it would be a terrible disruption of your time. 

So what we have done is to send our people out, after prior dis- 
cussion as to whom we wanted to see and under what circum- 
stances. For you to then suggest that not only do they have the 
right to have counsel but that you have the right to determine who 
should be present is, I think, awfully wrong. 

Mr. Donnelly. Mr. Chairman, may I try to make an effort to 
perhaps deal with your concerns? 

Mr. Weiss. Mr. Donnelly. 

Mr. Donnelly. As you may be aware, I have had some meetings 
with your staff and others as we have attempted to resolve these 
issues. I think it is important to say at the outset that no one, cer- 
tainly at this table or in the Department, is anything but very 
much aware of the procedures, the rights, the rules of the Congress 
of the United States in terms of the business that the Congress con- 
ducts. 

It is my understanding 

Mr. Weiss. And the Constitution. 



375 

Mr. Donnelly. These are constitutional rights, not only the Con- 
stitution but the statutes that the Congress has enacted, and in the 
policies of the House rules for the conduct of House business or the 
Senate, I assume, for the rules that the Senate conducts. 

Clearly, I am not a lawyer, so I am speaking to you as to my un- 
derstanding of these matters — counsel may differ with me, per- 
haps, but I believe this is essentially correct — in the matter of 
having the Congress conduct discussions within the executive 
branch, short of the subpena power, which as you say is something 
that all of us would seek to avoid because it simply sharpens con- 
frontation and polarization, the matter of how one conducts those 
discussions and investigations or any kind of those interactions is a 
matter of comity, and it is a matter 

Mr. Weiss. It is not a matter of comity. That is where you and I 
disagree. 

Mr. Donnelly. We may disagree on that. But it is my under- 
standing that when you would ask people to come up here to be in 
executive session or to be sworn in or in any other way to appear 
before you in executive session or appear before this subcommittee, 
all of the rules of the House and all of the statutes and all of those 
powers certainly do apply. Where you would ask to come into the 
executive branch and discuss and have an interaction of material 
and information that would come back to you, short of that sub- 
pena power we are trying to accommodate you. 

Mr. Weiss. You have not accommodated us. 

Mr. Donnelly. All of our efforts have been to accommodate you 
and provide you access to the information that you require and 
that you request in an orderly fashion that does not interrupt the 
mission of the Public Health Service. 

Mr. Weiss. Let's get it very clear and straight. I have a GAO in- 
vestigator; I have a staff investigator. I intend to have them go out 
in the field to the location of the Centers for Disease Control. I 
intend to have those people interview previously notified staff 
people of your agency. 

Will you, in fact, permit our staff or the GAO staff to interview 
those people on the premises without the presence of your manage- 
ment people? 

Mr. Donnelly. Will we permit that? Of course, we permit that. 
We have always permitted that. 

Mr. Weiss. Well, you did not permit it when my staff person vis- 
ited this past May. 

Mr. Donnelly. No, sir. I would disagree with you, Mr. Chairman, 
in one point that you made. The issue of whether or not an employ- 
ee is accompanied by someone is an issue of that employee's choice 
and solely that employee's choice, and not of management. 

Mr. Weiss. Well, it is the policy of this subcommittee that any- 
body who wants counsel present may have it. The subcommittee 
will not allow the presence of other staff or management personnel 
during interviews. We are not about to have employees of the Gov- 
ernment intimidated by top level bureaucrats. OK? 

Now, I would hope that, in fact, the cooperation would be genu- 
ine and not just rhetoric. 

Mr. Donnelly. Mr. Chairman, I trust that our cooperation has 
been genuine all along. It is my understanding that the things you 



376 

have required and needed and the exchanges we have had have 
been provided forthwith and promptly, as quickly as we can. 

Mr. Weiss. We have an internal memo dated May 5, 1983, of 
minutes from the NCI executive committee. It says: 

Program and intramural staff have the right to have an NCI representative be 
present during meetings with Congressional staff. Dr. Knipmeyer should be advised 
of Congressional staff requests for interviews and invited to attend. 

Mr. Donnelly. Well, Mr. Chairman, not seeing the memo you 
have in front of you 

Mr. Weiss. I will give you a copy. 

Mr. Donnelly. I don't know its origin or date in terms of the 
timing or sequence of these matters. I think as your staff has ad- 
vised you, given our discussions with them and our openness to 
come up and discuss these matters, if that memorandum did not 
reflect accurately the policy of the Secretary which I just an- 
nounced to you, I am sure the Department or the individual agency 
has, in fact, corrected that. Perhaps Dr. Henney would wish to 
speak to that. 

But I don't believe we have that kind of problem that exists 

Mr. Weiss. Please speak to that memorandum. 

Dr. Henney. I think the memorandum is consistent with what 
Mr. Donnelly was saying insofar as we were trying to give our em- 
ployees a choice as to whether or not they wanted any other indi- 
vidual staff member to be with them. Dr. Knipmeyer was to be con- 
tacted of any meeting only in her coordinating function in terms of 
congressional liaison activity, so that she would know when con- 
gressional staff were at the NCI and could see to it they were ac- 
commodated in terms of a room to look through materials, proper 
Xeroxing facilities, that sort of thing. 

Mr. Weiss. You are doing this for our benefit? 

Dr. Henney. It was the intent to accommodate your investiga- 
tion, yes. 

Mr. Weiss. Do you understand now that, in fact, we consider it 
inappropriate to have staff people of the agency in a position where 
they may feel they are being intimidated by top level supervisory 
staff? 

Dr. Brandt. Are you suggesting that even if an employee volun- 
tarily asks for someone else to be present with them, that you 
would deny them that right? 

Mr. Weiss. I would permit 

Dr. Brandt. Unless they are a lawyer. 

Mr. Weiss. I would permit them to have their personal counsel 
present. I would not put them in a position where they might feel 
intimidated by your management staff; that is right. 

Dr. Brandt. Does counsel mean a lawyer, attorney only? 

Mr. Weiss. Legal counsel. We don't think it is essential or neces- 
sary. There is no constitutional requirement for it. But, as a matter 
of policy, this subcommittee and this committee have taken those 
steps. I would hope that, in the future, you would follow this policy 
and not insist that an intermediary of your agency staff be put be- 
tween us and the Federal employee who is to be interviewed. 

Dr. Brandt. Nobody is attempting to do that. However, I think 
that if an employee — an employee, even though they work for the 



377 

Federal Government, still has some rights as a person. And it 
seems to me that should they choose to have — to ask for some- 
body's presence with them in order to see that their rights are pro- 
tected following the interview, that, it seems to me, is just sort of 
simple human decency or courtesy. 

Mr. Weiss. Well, we have given simple human decency and legal 
representational rights. What we are trying to do is to protect 
agency employees from having big brother watching over them as 
they talk to a Member of Congress or to the staff of the subcommit- 
tee. 

Dr. Brandt. Nobody is forcing them to have anybody with them. 
Nobody is forcing them to do that. 

Mr. Donnelly. Mr. Chairman, I think it is important for all of 
us to understand here that what you say is precisely what we are 
trying to accommodate in that no employee who needs to meet 
with one of your investigators — and we would ask them to cooper- 
ate in every possible way — needs to feel intimidated in either 
event, either by your investigators or your person, who certainly 
have no intention of being intimidated, or by our personnel. And 
that is why when people come to us and request of us what should 
we do, how can we be cooperative with the Congress, they are ad- 
vised of that right. 

Mr. Weiss. That is not what this memorandum says, Mr. Donnel- 

Mr. Donnelly. But that is what is, in fact, in place. 

Mr. Weiss. Well, let me again be very clear as far as this sub- 
committee is concerned. You do not have the right to interpose 
your management people between the committee and staff. 

Next area: You have a position of policy development — whatever 
that means — as being an area where you. Dr. Brandt, and the 
people under you, make a determination as to subject matters 
which you will not disclose to this subcommittee. 

What does that mean? What does "policy development" mean? 

Dr. Brandt. The only thing that I can think of has to do with 
budget, sir. That is the only issue that I am aware of that has come 
up. We are all, as members of the executive branch, bound by 0MB 
Circular A-10, which was first published November 12, 1976, which 
basically defines what our responsibilities are for disclosure with 
respect to the budget. That is an order that comes from the Presi- 
dent and came from President Carter initially — I guess President 
Ford initially — and then reinforced by President Carter, and now 
by President Reagan. As far as I know, that is the only issue that I 
am aware of. 

Mr. Weiss. So that there is no such thing as policy development 
as the basis for refusal of access to this subcommittee? 

Dr. Brandt. There is nothing that I am aware of. Perhaps you 
could give me an example of something that you are talking about, 
and I will try to deal with it. 

Mr. Weiss. We have a memo dated May 20, 1983, from Mr. An- 
thony L. Itteilag to OPDIV Executive Officers. It refers to provid- 
ing budgetary data to Congress. 

Dr. Brandt. Yes, sir. 

Mr. Weiss. It says that: 



378 

Statements of evaluation and opinion should be omitted. In instances where Con- 
gress has requested factual data, a separate narrative section which clearly outlines 
the administration's position and facts to support this position must be included. 

And then: 

All material submitted to the Congress must evidence the Department's support 
of the administration's stated policies. 

What does that mean? 

Dr. Brandt. I don't know, from what you have just read, what 
that means, sir. I don't know where that memo came from. 

Mr. Weiss. This was sent to us from CDC files by Dr. Foege. 

Dr. Brandt. We will be happy to look at it and try to determine 
what it means. But I don't 

Mr. Weiss. As far as budgetary items are concerned, is it your 
position that discussions pertaining to the fiscal 1984 budget — that 
is, memorandums, and all papers pertaining thereto — are matters 
which you are foreclosed or precluded from discussing or making 
available to this subcommittee? 

Dr. Brandt. Papers — the President has submitted to the Con- 
gress a budget. And the information pertinent to that budget is cer- 
tainly available. 

Mr. Weiss, it was just pointed out to me that in this memo you 
had quoted from the NCI, there is a statement at the end that per- 
haps ought to go in the record. It says: "Should an employee wish 
to meet with a congressional staffer alone, he or she is free to do 
so." 

Mr. Weiss. Is that the position now? 

Dr. Brandt. It has always been the position. Whenever they 
choose to do it 

Mr. Weiss. When Ms. Steinmetz, sitting next to me, went down 
to Atlanta, that was not the case. She was absolutely forbidden to 
meet with any of your staff people unless, in fact, there was some- 
body from the management staff present. 

Dr. Brandt. At that point in time, we had received no advance 
notification, and the Secretary had not set forth the policies under 
which we were going to deal. 

Mr. Weiss. The Secretary may not have set forth the policy. As 
far as advanced discussions are concerned, there were discussions 
with the employees who were to be seen prior to her Atlanta visit. 

Dr. Foege. Mr. Chairman, I think the fact is, Ms. Steinmetz did 
talk by phone to some of the people she wanted to see. We had no 
indication before her arrival that she wanted to look at files. And 
it was at that point that we raised the problem that we would have 
to remove identifiers first. So that was the real problem. 

We asked to get departmental help on deciding where to proceed 
with that. So that was the problem at that time. 

Mr. Weiss. I gather from what you are saying that as of this 
point there should be no problem as far as access is concerned to 
either files or to individuals, as long as we follow the confidential- 
ity procedure that we have agreed on. 

Well, I am pleased that we have that established. We will be 
having further hearings. I hope that we don't have to go through 
this again. 

Mr. Walker. 



379 

Mr. Walker. Thank you, Mr. Chairman. 

Mr. Chairman, I share your concern over our committee access 
to executive branch files and information; unnecessary obstruction- 
ism by executive agencies can exacerbate situations that can be 
more easily resolved through negotiation. Hopefully those negotia- 
tions have now come to fruition. 

But I would point out that this whole matter of access to docu- 
m.ents sometimes depends upon whose ox is being gored, too. 

The chairman of the full committee of this committee is a little 
less than enthusiastic about giving us access to information that 
we have needed recently with regard to the records of this commit- 
tee, public documents. 

When I asked to review transcripts of what went on in this com- 
mittee and in the published records of the committee, I was told 
that I personally would have to come and look at it, that I could 
not send a member of my staff to review that material. And in fact 
when I personally came down to look through the material and 
brought along a member of the staff, I had to have a member of 
the majority staff sit in during the period of time that I went 
through materials that are on the public record. 

So I would say that when we exert our constitutional preroga- 
tives here at times, we ought to be very careful that our own house 
is in order. In this case it is not. 

Let's get back to the issue of AIDS. I think that is something 
that we want to get discussed. 

As I sat here through the day yesterday and listened today to the 
testimony particularly from the leaders of the gay rights or homo- 
sexual activities groups, I had the feeling that the Department was 
acting in a vacuum. We were led to develop the impression that 
there is no interaction on the AIDS problem between HHS and a 
lot of these affected organizations. 

First of all, is that a correct impression? 

Dr. Brandt. No, sir, it is not a correct impression. 

I will let Dr. Foege begin to summarize this. But I think again, 
sir, I would like to point out that it clearly is not possible to inter- 
act on a frequent basis with every possible organization that may 
express an interest in this activity. We have, I think, made an 
effort to try to work with them, and indeed I might say that these 
groups have been very helpful to us. 

For example, in setting up the hotline, Ms. Apuzzo of the Nation- 
al Gay Rights Task Force was very helpful to us in giving us leads 
and so forth. Perhaps Dr. Foege could summarize some of the inter- 
actions we have had with the various gay organizations. 

Dr. Foege. I think, Mr. Walker, we have actually worked quite 
closely with the groups and many individuals in the groups. 

For instance, when the problem first came to light, we did a 
fairly large case control study of AIDS patients with matched con- 
trols to try to determine what the risk factors were. This was done 
in cooperation with the gay physicians organization in San Francis- 
co, the Bay Area Physicians for Human Rights. These physicians 
actually helped to get the control groups from their own patient 
groups. 

We have invited representatives of various gay groups to our na- 
tional meetings, for instance, the meeting we had in July of 1982 



380 

when we first looked at the problem of blood transfusions. We had 
the same representatives attend meetings early this year to review 
where we were on the transmission, and what we should be advis- 
ing for the donation of blood. 

We have met continuously with the gay groups at their own 
meetings to explain what we know about AIDS. We have had their 
involvement, their active involvement in preparing the Public 
Health Service prevention statement on how to reduce the rise of 
AIDS. 

I think we have had very close cooperation and collaboration 

with the gay groups. 

Mr. Walker. As I said in my opening remarks, I think what is 
important here is to begin to put some of this into perspective, and 
take a look at some of the charges made yesterday. 

For example, during testimony yesterday, one gay leader made 
the suggestion that there had been discrimination against homo- 
sexuals and persons of color as evidenced by the treatment of per- 
sons with AIDS. 

Under questioning, this individual was unable to be specific 
about her charges, which included, by the way, a statement to the 
effect that AIDS victims were being treated as "expendable." For 
the record, I would appreciate some response to these what I 
regard as reckless charges. 

Dr. Brandt. Ever since the situation with AIDS has become pop- 
ular in the media at least, the issue of bias toward homosexuals in- 
fluencing scientific decisionmaking and influencing responses has 
been repeatedly raised. It is one of those issues that you can only 
deny and only show that in fact we have approached this disease 
like we have approached virtually every other disease. 

I might call your attention to the fact that in this morning's New 
York Times Dr. Lawrence Altmann, a very distinguished medical 
observer, has written a comment summary called "It Takes More 
than Money to Conquer Diseases Like AIDS" And he points out in 
there that we have followed orthodox scientific precedents as we 
hoped to do all the way along. At no time, to my knowledge, has 
any of the biases, prejudices or other negative aspects influenced 
our decisionmaking solely because these people were homosexual 
or Haitian or any other group. In fact, they are people with a dis- 
ease, with a serious disease, and our principal goal is to help people 
who are sick. 

Dr. Fauci, who is here with us, treats most of the patients at the 
NIH Clinical Center. I am sure that since he is a physician to 
many of these patients, and the charge that he is treating them as 
if they were expendable, he may wish to say something. 

Dr. Fauci. Well, I think that really is a most extraordinary com- 
ment and charge, Mr. Walker. I think that anyone who has any- 
thing directly or indirectly to do with my staff and the group at the 
NIH who are directly involved in the care, both the physical and 
mental care of the patients who are suffering from this extraordi- 
nary disease, will be more than happy to attest to the fact that our 
sensitivity to them as individuals and as patients is what one 
would expect of any patient with any disease, and I can say with- 
out a doubt that to my knowledge there has been absolutely no dis- 



381 

crimination in any manner or form to any patient, subpopulation, 
either in fact or even by inference. 

Mr. Walker. And in fact one of the AIDS victims who testified 
here yesterday did say precisely those kinds of things about your 
staff. But again, I thought it was important to have it on the 
record. 

Dr. Brandt. Mr. Walker, I don't know how to put this charge to 
rest. We have repeatedly expressed our concern — quite frankly, 
early on my personal outrage — at a charge that I consider to be in- 
sulting to a lot of dedicated physicians and scientists who are 
trying to solve a problem, and the charge is just without founda- 
tion as far as I am concerned. If in fact there are any specific in- 
stances of it, I would love to know about them. 

Mr. Walker. Another charge that has been made is that the 
Public Health Service has not responded promptly enough to the 
AIDS problem. 

Now, early today we were given somewhat of a benchmark of 
what a prompt response might be by the people from the Public 
Health Service who indicated when they respond to the problem in 
their local areas, where there are affected populations, they re- 
sponded in terms of about mid-1981. 

Now, you talked a little bit about this in your testimony, I think. 
But I think, again for the record, could you tell us when the first 
AIDS cases were reported to you, when epidemiologists were sent 
into the field, and when NIH admitted the first AIDS patients? 

Dr. Brandt. All right. 

In the period of March and April 1981 was the first time that the 
cases began to be reported to the CDC. These were people with 
Pneumocystis pneumonia, and Kaposi's sarcoma, in young homo- 
sexual men. Since both of these are unusual events, CDC sent epi- 
demiologists into the field, who began to look into this situation 
within a matter of days of hearing of it. 

On June 5 the first publication of the MMWR, which listed these 
cases, we began that day to set up within CDC a surveillance of all 
cases. Eleven days later, on June 16, 1981, the first patient was ad- 
mitted to NIH. 

At the same time NIAID alerted people at its — by the way, these 
first five cases in Los Angeles were in fact discovered in an NIAID- 
supported facility, a sexually transmitted disease facility — I mean 
an immunological diseases facility— Center for Interdisciplinary 
Research and Immunologic Diseases, University of California, 
Davis — there. And the other persons were alerted to this problem, 
and work began, both within the NIH intramural program as well 
as grantees around the country who were competent and who had 
grant support already in place from the NIH, began to work on the 
problem. 

I think it is important that everybody recognizes that there is a 
great deal of flexibility in our grant system. That flexibility allows 
grantees with the permission of the NIH, and with notification to 
the NIH, to begin to aim their work at serious public health prob- 
lems that need solutions. So that by September 1981, roughly less 
than 6 months after the first cases were reported, the first work- 
shop was held in an attempt to try to define a scientifically respon- 



26-097 O— 83 25 



382 

sible agenda to be followed. So I believe the response was as rapid 
as one could hope for. 

Mr. Walker. So using that mid-1981 benchmark, by mid-1981 
you had become cognizant of the problem, had put epidemiologists 
in the field, and had admitted your first patient to an NIH facility; 
is that correct? 

Dr. Brandt. Yes, sir, and not only that. We already had the ear- 
liest clue that we had about this disease, which turned out not to 
be correct, had to do with the use of a substance, amyl nitrate 
which comes in a little capsule that can be broken and inhaled, 
called poppers on the street. And the histories from the early pa- 
tients would indicate that these people used large numbers of pop- 
pers. 

Now, amyl nitrate had previously been and occasionally now is 
used by patients with heart disease, but usually in relatively small 
amounts. So work had already begun to try to determine whether 
or not that in fact might have led to this drastic immune suppres- 
sion. And it was early in the fall that that was ruled out as a real 
possibility. 

Mr. Walker. Mr. Chairman, I do have some additional questions. 

Mr. Weiss. Thank you, Mr. Walker. 

Mr. Levin? 

Mr. Levin. Let me ask a series of questions relating to budget 
matters. I hope that you can answer them— regarding the Presi- 
dential memo of 1976. 

What was the Department's position regarding the $12 million 
supplemental for AIDS? 

Dr. Brandt. We requested, Mr. Levin, early on to transfer funds 
across appropriation lines — I mean, the technical term for it, I 
cannot tell you. I never can keep that straight. 

Anyway, we have requested permission of the Appropriations 
Committee to transfer $12 million from activities of lesser priority 
into this program. Instead, as you know, the appropriations com- 
mittees of both the House and Senate put in a $12 million supple- 
mental. 

Mr. Levin. In a word, the Department took the position that 
there should not be more money granted to the Department, but it 
should take money from other places within the Department's 
budget. 

Do you oppose the addition of money for want of authority to 
transfer? Isn't that in simple English an accurate summation of 
the Department's position? 

Dr. Brandt. I guess you could say it is accurate. What we did — I 
would put it more positively. 

We proposed a transfer of money into this problem by the Con- 
gress. 

Mr. Levin. You took the position you did not want more money. 
You wanted the authority to transfer. 

Dr. Brandt. We took the position that we wanted the authority 
to transfer. 

Mr. Levin. But not more money. 

Dr. Brandt. We cannot request more money. 

Mr. Levin. Did you oppose it? 

Dr. Brandt. I don't know that we did either one. 



383 

Mr. Levin. All right. From what activities 

Dr. Brandt. In any event, the President signed the bill, as you 
know. 

Mr. Levin. All right. But your position on that may have some 
relevance as to what you see as the appropriate battle plan of the 
Department. 

From what activities were you proposing to take the $12 million? 

Dr. Brandt. Actually, I am going to have to provide that for the 
record because I really don't remember. It was not from other re- 
search programs. 

But I don't remember the specific activities. I will be happy to 
try to provide that. 

Mr. Levin. All right. I was looking over the budget levels for 
CDC. You mentioned in your testimony the various activities of 
CDC. These documents are always complicated. 

But looking at budget authority, the figures show that the budget 
authority for 1982 for CDC, $299 million, rounded off to $800 mil- 
lion. For 1983, $334 million. 

The proposed budget authority for 1984, $270 million. Could you 
tell me when or how with that kind of a requested level you felt 
that CDC and the figures are not so different for other parts of the 
agency, at least some of them, how CDC could carry on an ade- 
quate effort in this area in 1983 and 1984 when the administration 
was requesting a budget level for 1984 of $64 million less than 
1983. 

Dr. Brandt. Well, there is a very simple explanation for that, 
sir. There is $80 million of the $334 million for a block grant — in 
the 1984 budget, in the President's budget, that block grant has 
been transferred out to my office. 

So to get comparable figures, you would have to subtract roughly 
$84 million from the $334 million, giving you a figure of approxi- 
mately $250 million, compared to $270 million. 

Mr. Levin. All right. So you are saying the figure for 1984 is 
$270 million versus $250 million for 1984, and how about for 1983 
and how about for 1982? 

Dr. Brandt. I don't have the 1982 figures. 

Mr. Levin. Let's take the National Cancer Institute. I would ap- 
preciate your supplying for the record the figures for 1982. 

Dr. Brandt. All right, sir. 

[The information follows:] 



384 

Centers for Disease Control Budget Figures by Year 

1, Comparable (exclude block grant) 

1982 - $231,349,000 

1983 - $267,147,000 

1984 - $254,423,000 

2. Noncomparable (include block grant) 

1982 - $312,949,000 (including $81,600,000 block grant) 

1983 - $353,476,000 (including $86,329,000 block grant) 

1984 - $254,423,000 (excluding $86,329,000 block grant which 

is included in JBHff budget) 
OASH 

Mr. Levin. When the block grant money is included in there. For 
the Cancer Institute, the proposed level for 1984 is $989 million; for 
1983, $983 million; for 1982, $986 million. 

How do you fit into those budget figures a major assault on 

AIDS? 

Dr. Brandt. I think, sir, that the issue is an attempt to— of 
course, NCI is not the only institute, in the first place. Indeed, a 
major part of our effort will be in NIAID, because this is an infec- 
tious disease, and a sexually transmitted disease. 

But it depends, I guess, upon— it is very clear that the issue with 
funding research is one of attempting to develop priorities. As you 
know, in the President's 1984 budget, as submitted to the Congress, 
we have recommended that moneys be transferred from some of 
the centers' program into the grants program. 

It is through that mechanism that we would fund additional re- 
search grants. 

Mr. Levin. The NIAID request shows $281 million for 1984, com- 
pared with $273 million for 1983. So if there is going to be heavy 
reliance on that institute, you are talking about a proposed in- 
crease of $8 million, which I think raises dramatically the request 
as to your battle plan. 

We have heard at the same time from several people, including 
people who are scientists, who presumably are very well versed in 
research matters, that an effort ten times what is being contem- 
plated could be well used. 

Let me ask you not only to comment on that, but more impor- 
tantly, what do you think is necessary in the way of efforts by the 
Department, funded through the Department, to tackle this chal- 
lenge? 

Dr. Brandt. Well, what we need at the present time, sir, are 
ideas. I mean, we need some insights, and some fresh insights, and 
some ideas that will allow us to get a breakthrough in this effort. 

Now, I have heard those figures loosely tossed around, and, 
frankly, I don't know what is included in those numbers. But I can 
give you the following information. 



385 

This is a disease that, under our current operating plan, we be- 
lieve is a virus. We believe this virus is transmitted sexually and 
through blood; that it has a long incubation period. 

We, therefore, have our plan developed along three basic lines. 
The first is to attempt to further define the characteristics of those 
people who develop the illness, that is, those who are at risk, and 
appropriate blood tests and other tests to try to determine ways to 
obtain an early diagnosis. 

The second line of attack is to identify the etiologic agent which 
is, we feel, a virus. As you know, three different viruses have been 
isolated from patients with AIDS — CM, EB virus, and the human 
T-cell leukemia virus. 

Whether or not these are opportunistic or whether or not they 
play a role in the development of the disease at this point in time 
is not clear. 

The third main line of research is towards therapy. Here, again, 
we have basically two, really three lines of research. One is aimed 
at treatment of the complicating illnesses, i.e., Kaposi's sarcoma, 
Pneumocystis, and so forth, for which we have some treatment that 
is working and, therefore, we have been able to get people over 
that part of their disease. The second is to try to restore the 
immune system. That includes such things as bone marrow trans- 
plants, which have been carried out at the NIH Clinical Center. 
Third is to augment the immune system through the use of such 
things as alpha or gamma interferon, and more recently, the hu- 
man trials now underway on a substance known as interleukin-2. 

Now, given all of that, and given that we are headed down all of 
those lines, the question is what kind of research, further research, 
is needed. We need, we believe, additional understanding of basic 
virology, additional understanding of basic immunology, additional 
understanding of other aspects related to that. 

If you take at the NIH all of the money that is currently being 
expended in those areas, it adds up to $166 million in fiscal year 
1982, any one of which could lead us down to a breakthrough with 
this illness. I am not sure, quite frankly, what further activities we 
could undertake at the present time in a reasonably meaningful 
way. 

We have had, as I testified, a lot of outside consultation, a lot of 
competent scientists. We have advisory groups at every one of 
those institutes who are outstanding people in the field, who are 
aware of what is going on, who give us advice constantly. We have 
tried to follow that advice. I think we are pursuing all of the rea- 
sonable scientifically responsible pathways at the present time. 

Mr. Levin. My time is up. Let me just give you the advice of 
someone quoted in the same article that you referred to in the New 
York Times of this morning. 

Dr. Richard Krause is Director of the National Institute of Aller- 
gy and Infectious Diseases, just one of the NIH member institutes 
that have appealed for more AIDS researchers. 

Dr. Krause says he has shifted money from other projects to finance some AIDS 
research because it was so pressing a problem. But he has also expressed deep con- 
cern that unless more new funds become available for AIDS, valuable projects in- 
volving other diseases might not be done. 



386 

The tragic possibility exists, he said, that, "the answer to AIDS may come from 
the kind of research activity in basic virology and immunology that might go un- 
funded." 

Thank you, Mr. Chairman. 

Mr. Weiss. You don't want to comment on that? 

Dr. Brandt. Well, that certainly is the quote in the paper from 
Dr. Krause. I have to agree with that. 

Mr. Weiss. Pardon? I missed the closing words. 

Dr. Brandt. What I said was that that is certainly the quotation 
that is in the newspaper; yes, sir. I agree. I agree with Dr. Krause 
in the following sense. I think that the answer to AIDS may very 
well come from the kind of research activity that 1 think is under- 
way. It is quite possible that one of the grants is unfunded. But we 
have had unfunded grants throughout history. That is not going to 
change. 

I think we need some specific advice as to where that money 
might wisely be spent, what kind of research. We are, in fact, 
bringing in consultants who are knowledgeable and are competent. 
We are attempting to follow their advice. 

Mr. Weiss. Mr. McCandless. 

Mr. McCandless. Thank you, Mr. Chairman. 

Doctor, yesterday we heard testimony which leveled certain criti- 
cisms at the Department which you represent. I would like to go 
over a few of these and for the record get your response. 

One of the criticisms was, that to date there had been no conven- 
ing of the professionals, who are responsible, on a nationwide basis, 
for coordinating the research program. 

I found that a little difficult to understand. Would you respond 
to that? 

Dr. Brandt. It is absolutely not correct. That is the reason that I 
find it difficult to understand. It clearly means whoever said that 
wasn't at one of those meetings, perhaps. But we have had repeat- 
ed meetings. As a matter of fact, the most recent one we had was 
July 19, when the Blood Products Group met to advise us about the 
safety and purity of factor VIII. 

The National Cancer Institute's Board of Scientific Counsellors 
and the National Cancer Advisory Board have been involved. The 
National Institute of Allergy and Infectious Diseases' board of sci- 
entific counselors has repeatedly sought advice from advisory 
groups. We have called together ad hoc groups to deal with prob- 
lems. Indeed, I have outlined a number of these in my testimony. 

They have certainly been involved. We fully expect them to con- 
tinue to be involved. 

Mr. McCandless. Another was, that there is no overall plan of 
attack or direction for the purpose of ultimately arresting the dis- 
ease. 

Dr. Brandt. I think that my testimony is, in fact, a recitation of 
the plan of attack, sir. 

Mr. McCandless. I was interested in the comment that you 
made concerning $166 million worth of research. In the comment 
you made, I was left with the impression that a lot of the research 
that is being done in other fields has a parallel to the research that 
is necessary in the field of AIDS. 

Is that a correct assessment of what it was you talked about? 



387 

Dr. Brandt. Yes. We have a disease here that is an attack on the 
immune system of the body. 

Mr. McCandless. For a reformed used car salesman turned poli- 
tician can you help me a little bit. 

Dr. Brandt. Yes. The immune system 

Mr. McCandless. I mean as far as the parallels are concerned 
with other diseases, or something that we can relate to as laymen. 

Dr. Brandt. All right, sir. We have a disease that involves the 
body's ability to respond to — particularly to infections, and to other 
stimuli. 

The parallel kind of research would be to try to understand how 
a normal functioning system responds to infections, because once 
we understand that, and knowing somehow or other what the 
defect is, we can better deal with the defect in these people. There- 
fore, the whole area that is attempting to understand the body's de- 
fense systems relates, indirectly I would agree, but nevertheless, re- 
lates to AIDS. 

Second is attempting to understand the particular blood cells in- 
volved. They have a name called T-cells, which is sort of a code, but 
nevertheless, trying to understand how those cells actually func- 
tion, what destroys them, what enhances their growth, et cetera, is 
another area directly relevant to AIDS. 

Finally, trying to understand better the way in which viruses 
can operate. Here we have what appears to be a virus that has 
some sort of direct influence on the body's defense system, and 
that, as far as I know, is virtually unheard of. I have a couple of 
virologists here who can comment on that, if you would like. 

To understand better the biology of these organisms so that we 
can understand how they might function, it seems to me is critical. 

If you add up all of that research that is going on at the NIH, 
that is relevant to this particular problem — admittedly, it covers a 
whole lot of other problems, too, and admittedly it is not directed 
exclusively at this disease — it adds up to be $166 million. 

Mr. McCandless. I would like to get one more question in before 
the chairman puts the gavel down on me. 

Let's take a fictitious time line for purposes of our discussion. 
This time line represents your Department's projected accomplish- 
ment line as to what you feel your responsibility is and what you 
hope to accomplish within the time, given certain parameters. 

Would you say that the Department is on schedule as far as its 
time line is concerned? If it is, great. If it is not, what do you sug- 
gest should be done to put you back on the time line? 

Dr. Brandt. It is always difficult, I think, Mr. McCandless, to try 
to estimate when you are going to discover something in science. I 
think it is probably better for me to talk about my personal time 
line. 

My personal time line, we are way behind, because, in fact, I was 
hopeful that certainly by the end of this year that we would have 
the organism isolated, would be working on a treatment, and per- 
haps a vaccine. 

We have not done that yet. The disease has turned out— I think 
the further we get into it— to be even more complicated every time 
we learn something new, it turns out to be somewhat more com- 
plex. 



388 

I think in terms of the overall research plan that we have been 
developing, that we are on course with respect to the directions 
and the types of research that we have needed. We have not at the 
moment obtained any additional leads that would cause us to devi- 
ate from the course that we are currently on. From that stand- 
point, I would say that we are on time. 

From the standpoint of those people who are suffering from the 
illness and who are at risk of the illness, we are clearly way behind 
in terms of our ability to help them, and I deeply regret that. But I 
don't at the same time fault the scientific community that has ad- 
dressed itself to this issue. The easiest thing in the world right now 
is to be very critical of that. 

In fact, these people have devoted a great deal of their time and 
their effort and their brains to try to solve this problem. As long as 
these young men and others are suffering from this illness, we are 
going to solve it and we are going to solve it as soon as we possibly 
can. 

Mr. McCandless. My time is up, Mr. Chairman. 

Mr. Weiss. Thank you very much, Mr. McCandless. 

Dr. Brandt, you have noted that all of us on both sides of the 
aisle have pressed you on these budgetary issues, specifically on 
how much is needed, how much is being spent, how much are you 
requesting, and so on. 

I guess you have to place that within the context of the declara- 
tion that you had made and you repeated here today, and which 
the Secretary, Mrs. Heckler, has made, that you consider AIDS to 
be the No. 1 health priority concern of your agency. That is cor- 
rect? 

Dr. Brandt. That is a correct statement; yes, sir. 

Mr. Weiss. Now, the question I think that we are trying to tie 
down, is how is that concern reflected— not in sympathy, not in 
compassion, not in words, not in rhetoric, but in dollars and cents 
research efforts expended to try to get to the bottom of this epi- 
demic. 

Now, you had responded to Mr. Levin's questions earlier about 
the requests that were made for the supplemental fiscal 1983 ap- 
propriation. I understand that this is not the only problem that you 
are concerned with, and therefore perhaps your recollection as to 
what transpired in the chronology of events leading to that request 
may have become a little bit vague. But, because you maintain that 
AIDS is the No. 1 priority, and because the dollars that are availa- 
ble have been criticized as being woefully inadequate, I want to 
take you back through that chronology. 

I have the Congressional Record excerpt of May 25, 1983, when 
the House in the Committee of the Whole, discussing the supple- 
mental appropriation on the floor, provided $12 million in new 
moneys for AIDS in fiscal 1983. 

One of the people who spoke in the course of that debate was Mr. 
Conte of Massachusetts, who is the ranking minority member on 
the Labor-HHS Appropriations Subcommittee, and the full Appro- 
priations Committee. He was very chagrined. 
He said — I am quoting now: 



389 

Let me inform the members of this body that concern over the funding for AIDS 
research was expressed by every member of the subcommittee during the hearings 
that the subcommittee has been conducting on the budget. 

Every agency involved in the investigation and research on AIDS was asked to 
describe their efforts and to indicate what more they could be doing, what more 
could be done. 

They all stated that they had adequate resources. 

Then he says that he is inserting into the Record the transcript 
of what transpired in the subcommittee's April hearings. Here is 
an exchange involving Dr. Foege's testimony before that subcom- 
mittee. 

After Dr. Foege had gotten through describing what was happen- 
ing in relation to AIDS, the number of cases and so on — this is at 
page H3342 of the Congressional Record of May 25, Mr. Conte says: 

That is frightening. Are you equipped now to go ahead with your work on this? 

Dr. Foege said: 

As we have in the past when we have a health emergency, we simply mobilize 
resources from other parts of the center. In 1982, we spent $2 million on AIDS, even 
though we did not have a budget line item for AIDS. 

This year we have $2 million in the budget and we will probably spend about $4.2 
million, the difference again, we will mobilize from other parts of the center. If we 
reach a point where we cannot do that, of course, then we will come back and ask 
for additional funds, but at the moment that is the way we intend to handle it. 

Mr. Conte. You are equipped to go ahead with it? There is nothing that is holding 
you back? 

Dr. Foege. That is the way we have operated for many years — go ahead and take 
funds from another part of the center when an emergency requires it. 

Now, that hearing was held in April 1983. The reason that con- 
cern was expressed on the floor by the subcommittee chairman Mr. 
Natcher and Mr. Conte, the ranking member, was that apparently 
sometime around May 13, Dr. Foege sent a memorandum to the 
Assistant Secretary for Health, Dr. Brandt, which outlined for the 
first time a detailed description of resource needs for expanded 
projects for fiscal year 1983, the current fiscal year, the same year 
that was being discussed in the Appropriations Subcommittee in 
April. 

In that memo, you talked about surveillance. Dr. Foege, for 
$264,000. You spoke about epidemiologic studies, investigations, 
needing $140,000. Laboratory studies, investigations, $335,000. Res- 
toration of funds diverted from other CDC activities in fiscal year 
1983, $1,465 million, for a total of $2.25 million. 

Now, what happened between your testimony in April before the 
subcommittee and the early part of May when you advised Dr. 
Brandt that, in fact, you could use some additional moneys to the 
tune of $2.25 million? 

What did you learn during that timeframe or had you known 
previously that, in fact, you needed these additional funds? 

Dr. Brandt. I would like to go back to 1981 for a moment to put 
this thing in some perspective. In testimony before and in the 
President's budget estimate submitted to the Congress for fiscal 
year 1982, the Public Health Service requested $20 million for use 
in emergencies from the Congress. 

This was turned down by the Congress. Instead, we were in- 
structed to deal with emergency funding in the same way as we 
had always dealt with this, which was to make the expenditures 



390 

and then go back and request funding— deal with the problem and 
then go and request funding from the appropriation committees. 

I testified on that appropriation. It was sent up as a part of the 
President's budget. Secretary Schweiker testified on this, and so 
forth. 

We, therefore, have been responding to emergencies of all kinds 
since that time, and the Congress has always responded when we 
have come in and requested the money 

Mr. Weiss. Now, I would like you to answer my question. In 
April of 1983, in testimony before the Subcommittee on Appropri- 
ations in your area, CDC said that it didn't need any authorization 
for any additional money or transfers, and that Dr. Foege would 
spend $4.2 million instead of the appropriated $2 million by an in- 
ternal shift of funds. 

Then in May, about the 18th of May, you notified the Appropri- 
ations Committee that the Public Health Service could use a $12 
million transfer. What I am trying to determine is when was that 
determination made, how was that determination made, did you 
know it prior to April, did you discover it between April and your 
testimony and May 12, May 18? 

Tell me about the change in position. 

Dr. Brandt. We have during that period of time and continuing 
to the present time almost continually evaluated where we stand 
on AIDS, where we stand both in terms of science and in terms of 
monetary needs. 

I think you will notice, sir, if you read my testimony, which is 
not reproduced in this particular colloquy, but if you read the testi- 
mony of Dr. Foege and others, you will see that in each case they 
say, and I quote from Dr. Foege, "If we reach a point where we 
cannot do that, then we will come back and ask for additional 
funds." 

We were reviewing this process, as I testified in the appropri- 
ations' hearings, virtually on a week — indeed, not virtually — exact- 
ly on a week-by-week basis to try to see where the leads were, 
where we might go. 

At that point in time, indeed, we were anticipating we might get 
a breakthrough somewhat earlier than we did. On May 9, Mr. 
Natcher, chairman of our Subcommittee on Appropriations, sent 
me a letter requesting that I give him an analysis of the budgetary 
needs and so forth. We immediately then reanalyzed the whole 
budgetary situation. It was on that basis that I requested the 
memorandum that Dr. Foege and Dr. Hayes and other agency 
heads, review their needs. 

We discussed them. The memo of May 13 that you have quoted 
from Dr. Foege was his response to my request — and then my 
letter to Congressman Natcher of May 18 was as a result of that 
whole thing. 

The situation changes all the time, Mr. Weiss. We are dealing 
with a very dynamic situation with this disease. We were attempt- 
ing, as we have— the Public Health Service has been set up to— 
handle emergencies since 1798. It is continuing to do so. We have 
always pulled that money from other sources, and then as the situ- 
ation got to the point where we needed additional money, we have 



391 

come in and asked the Congress. That is the way the Congress has 
asked us to behave. That is what we do. 

Mr. Weiss. Dr. Foege, I would like your response to the question. 
Again, let me state it. In April 1983, you appeared before the Labor 
HHS Appropriations Subcommittee and were pressed according to 
Mr. Conte by every member of that subcommittee for your descrip- 
tion of the problem and what you needed. 

You testified according to the transcript that you didn't need any 
more money, if you needed anything more you had enough other 
resources within the Agency to transfer to AIDS — and you judged 
that you would be spending about $4.2 million in fiscal year 1983. 

According to Dr. Brandt, on May 9, the Department received a 
letter from Mr. Natcher, who chairs that subcommittee, which 
says, "Hey, fellows, reassess, reanalyze, tell us what your needs 
are." 

Between the 9th and the 13th, you analyze, and for the first time 
conclude that, indeed, within various agencies of HHS, you can, in 
fact, use $12 million. 

Now, does that seem to be a coordinated planned approach deal- 
ing with that disease? Was it truly the first time that you discov- 
ered, when Mr. Natcher asked HHS for a reanalysis, that instead 
of needing maybe $4.5 million, you were going to need $12 million 
more for the balance of this fiscal year? 

Dr. Foege. Mr. Chairman, let me put it in perspective first. 

I did not request $12 million. I requested $2.25 million. 

Mr. Weiss. For the Centers for Disease Control? 

Dr. Foege. That is right. 

Mr. Weiss. How about for the other component agencies? 

Dr. Brandt. I made a request for the whole Public Health Serv- 
ice, including the Centers for Disease Control. There is another 
thing that happened in the interim, Mr. Weiss, with respect to 
NIH. That is, we had put out a request for applications and we re- 
evaluated the worthy applications that came in. 

Precisely, if you look at the justification that we sent to Mr. 
Natcher, and if you look at subsequent information which was 
made available to Chairman Waxman, all of which we would be 
happy to provide to you, it is precisely the funding of grants, addi- 
tional grants, that came in response to our request, subject to that 
testimony, that we have requested the money to fund. 

[Material referred to follows:] 



i. 



r 



392 



DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 



National Institutes of Health 
Bethesda. Maryland 20205 



June 10, 1983 



The Honorable Henry A. Waxmcn 
Chainnan, Subconmittee on Health 

and the Environment 
Committee on Energy and Commerce 
House of Representatives 
Washington, D.C. 20515 

Dear Mr. Waxman: 

We have been asked by your staff to provide information on our current 
research efforts on Acquired Immune Deficiency Syndrome (AIDS) and 
projections for estimated obligations and spending for the duration of 
FY 1983 if we receive additional funds. 

As you know, on May 9, William H. Matcher, Chairman of the House 
Appropriations Subcommittee on Labor-HHS and Education asked Dr. Edward 
N. Brandt, Assistant Secretary for Health, how much in the way of 
additional resources for AIDS activities could be effectively used in 
the current fiscal year and an explanation of how those resources would 
be used, if provided by Congress. 

Dr. Brandt responded on May 18 with a request for discretionary 
authority for the Secretary, Department of Health and Human Services 
(HHS) to transfer up to $12 million for AIDS activities across 
appropriations lines of HHS. In floor action by the House on the 
FY 1983 supplemental, $12 million was added to the bill for AIDS 
activities without granting the transfer authority. The Senate 
Appropriations Cotmittee has also included the $12 million for AIDS in 
Its version of this bill. 

In the following paragraphs, we describe current AIDS activities as well 
as our plans for additional funds if they become available. 

National Cancer Institute (NCI) 

CURRENT EFFORTS ($4.4 million) 

Extramural ($2.8 million) 

A Request for Application (RFA) process was begun In FY 1983 to support 
a multidisciplinary, multi-institution "Working Group" to study the 
etiology and treatment of AIDS and Kaposi's sarcoma. Although this RFA 
was originally budgeted at $1.3 million, NCI has provided a total of 
$1.8 million for this project. Awards are made as cooperative 



393 



agreements so that NCI staff can serve as a resource for information on 
the activities of various scientists and can act to facilitate 
collaboration among involved researchers. With the cooperation of the 
awardees, collaborative areas are Identified and developed. The purpose 
of this Cooperative Agreement is to encourage such research by providing 
support to institutions with an interest in the problem, access to a 
population of affected patients and laboratory facilities and personnel 
appropriate to the conduct of such research, Tne intent of this award 
is to encourage innovative, multidisciplinary studies of this problem. 

Specific research currently underway with support from this RFA 
includes: 

- Animal studies on the immunosuppressive potential of human 
seminal plasma and cytomegalovirus (CMV), which causes a type of 
infection seen in AIDS patients. Seminal plasma and CMV have 
been suggested by investigators as possible causal agents for 
AIDS. 

- Extensive virological and immunologic studies on a group of AIDS 
patients. The viruses to be studied include CMV, Epstein-Barr 
virus (EBV), and human T-cell leukemia-lymphoma virus (HTLV). 
EBV and HTLV have been associated with some rare cancers, but at 
present the association between these viruses and AIDS is 
uncertain. 

- Inmunologic and virologic studies to identify and characterize 
the similarities and differences of AIDS patients who belong to 
different groups at risk of developing the disease. 

- Genetic studies of specimens from AIDS patieits to look for 
viruses and cancer-related genes that may play a role in causing 
the disease. 

- A three-year study of early defects in the immune function of 
AIDS patients that might permit early diagnosis. Laboratory 
studies will be conducted to see if alpha-interferon, an 
antiviral agent that is produced by the body, might be a 
diagnostic indicator for AIDS. Blood cells of AIDS patients 
grown in the laboratory fail to produce normal amounts of alpha- 
interferon for unknown reasons. 

- A five-year study to develop inmunologic profiles of AIDS 
patients and apparently healthy individuals at risk for the 
disease, including the occurrence of persistent lymphadenopathy 
as a possible precursor of AIDS. 



394 



NCI is also funding regular research project grants which have a direct 
relevance to AIDS. For example, currently funded grants include funds 
for studying the treatment of Kaposi's sarcoma and other sarcomas. The 
two objectives of a large NCI human cancer serology program project 
grant, for example, are on problems which may relate to these 
patients. Th.ey are: (1) serological definition and biochemical 
characterization of distinctive cell surface antigens of human cancers 
and, (2) imraunovirologic analysis and biochemical characterization of 
human cancers of suspected viral etiology. 

Since the development of Kaposi's sarcoma is thought to be related to a 
dysfunction of the inmune system, research involving iimiunodeficiency, 
or the itimune system as a whole, may hold the key to understanding the 
genesis and etiology of this rare malignancy. Another of NCI's 
comprehensive program project grants provide resources for investigating 
the relationship of the development of the lymphoid system and 
immunodeficiency diseases and human cancers. This program project will 
coordinate and focus the efforts of ten interrelated projects working on 
both clinical and fundamental perspectives. 

Laboratory and technical support for NCI studies of patients with AIDS, 
or at risk of developing it, is being provided by portions of four 
contracts which were originally established to provide program-wide 
support for a variety of research projects in the Environmental 
Epidemiology Branch (EEB), Division of Cancer Cause and Prevention, 
NCI. The Environmental Epidemiology Branch conducts studies to define 
the distribution and determinants of cancer. These activities include 
the formulation of hypotheses using national and other data resources 
and the testing of these hypotheses in analytic case-control and cohort 
studies. Descriptive studies are conducted at whatever locales within 
the United States offer the greatest likelihood of producing meaningful 
new clues to cancer etiology. These contracts are now being employed to 
provide support for studies relevant to AIDS. 

Intramural ($1.6 minion) 

Approximately $1.6 million of NCI's 1983 funds are devoted to AIDS 
intramural research. 

The NCI supports a large intramural program which investigates the 
limiune system, the dysfunction of which apparently allows the 
development of diseases such as Kaposi's sarcoma and other opportunistic 
infections associated with AIDS. 

In addition, NCI is conducting research specifically devoted to AIDS. 
Researchers in the Laboratory of Pathology are examining tissue 
specimens taken from AIDS patients during surgery to examine the 
immunological characteristics of certain AIDS-related lymphomas. The 
Field Studies and Statistics Program is conducting epidemiological 
studies of immunological profiles of healthy homosexual men and profiles 
of hemophiliacs with symp^ms, as well as individuals with AIDS or 



395 



members of population groups at risk of developing AIDS. Also, Division 
of Cancer Treatment investigators are using alpha-lymphoblastoid 
interferon in combination with chemotherapy to treat Kaposi's sarcoma in 
AIDS patients. 

PROPOSED ADDITIONAL NCI FUNDS ($3.3 million) 

Extramural ($2.8 million) 

If additional funding is made available for FY 1983, NCI will fund up to 
12 additional responses to the current Request for Application, for a 
total of about 70X of the approved applications. 

The science which would be supported with the additional money includes: 

the nature of the defective inmunoregulation in AIDS; 

etiology and immunological basis of AIDS; 

interferon and the etiology of AIDS; 

noninvasive diagnosis of Pneumocystis carinii in AIDS patients; 

development of laboratory animal models for AIDS and Kaposi's Sarcoma; 

imnunodeficiency in hemophilia; 

the role of cytomegalovirus (CMV) in AIDS. 

In addition, grant proposals received through the normal peer review 
process will be tracked closely and the review and approval procedures 
will be expedited to hasten funding for research project grants which 
otherwise would not be awarded until FY 1984. 

Intramural ($0.5 million) 

With additional funds, NCI could increase the efforts of its newly- 
created Task Force on AIDS, and provide a central focus and thrust for 
new initiatives on AIDS emphasizing the possible role of etiologic 
agents. Dr. Robert Gallo, whose unique expertise in the isolation of 
human oncogenic viruses is world renowned, will act as the Scientific 
Director of the Task Force effort, which will consist of intramural and 
contract-mediated components to deal primarily with the role of HTLV as 
a potential causative agent in AIDS. This expanded intramural effort at 
NCI locations in Bethesda and Frederick will each require renovations 
and equipment connensurate with increased safety requirements for both 
AIDS- and HTLV-containing samples. Accordingly, a portion of the 
additional funds will be used for renovation of a high-containment 
facility at Frederick. Also, several laboratory technical personnel 
will be added to this effort. Examination of samples of electron 
microscopy, fluorescence-activiated cell sorting, radioirmune assays, 
virus isolation and concentration, and production of monoclonal 
antibodies will be carried out by NCI's technical support contractor 
with the direct input of Dr. Gallo. 

In total, NCI's AIDS budget, including the proposed additional funds, 
would be $5.6 million for extramural and $2.1 million for intramural 
research. 



396 



National Institute of Allergy and Infectious Diseases (NIAID) 
CURRENT EFFORTS ($4.1 minion) 
Extramural ($2.3 mniion) 

Of $i.4 million allocated for grants, approximately $1 minion has been 
used to fund four appncations in response to the NCI RFA. 

These include studies on the following: 

potential drug treatments for Pneumocystis carinii pneumonia in 
an animal model; 

the prevalence and transmission of cryptosporidiosis, a recently 
identified parasitic disease that can cause severe and 
potentially fatal diarrhea in the immunosuppressed AIDS patients; 

the development of opportunistic infections in infants born to 
mothers who were sexual partners of AIDS patients; possible 
routes of transmission of AIDS among contacts of adult 
heterosexual patients; 

evaluation of chemotherapeutic and naturally occurring substances 
for the treatment and prevention of AIDS, as well as the study of 
iimiunologic defects in AIDS patients and the possible 
relationship of cytomegalovirus to the cause of AIDS. 

The remaining $0.4 million will support research project grants not 
submitted in response to the RFA, including the effects of cytomegalo- 
virus on cell -mediated immunity, plus AIDS projects at ongoing NIAID 
Sexually Transmitted Disease Centers and Centers for Interdisciplinary 
(Research on Iimiunologic Diseases which Include: a study to define the 
interrelationship between the "AIDS prodrome wasting syndrome" and full- 
blown AIDS in case control and cohort studi3s; a study of life style and 
other factors influencing occurrence and reversibility of AIDS in 
homosexually active young males, including association of sexual 
practices with altered helper /suppressor T-cell ratios; and a study 
analyzing T-lymphocytes of AIDS patients by molecular hybridization with 
specific DNA probes in order to detect and quantitate the number of 
genome copies of cytomegalovirus and herpes simplex virus type II DNA in 
these lymphocytes. 

On May 9, 1983, NIAID issued an RFP ("Study of the Natural History of 
Acquired Intnune Deficiency Syndrome (AIDS) 1n Homosexual Men") which 
will support a prospective study with the following specific objectives: 

— To observe and study the natural history of the disease in 
enough persons who are uninfected at the outset to yield a 
number of cases of AIDS sufficient for meaningful estimates of 
risk; 



397 



— To build a repository as a national resource for specimens 
and data from men who traverse the entire course from well to 
ill; it would permit testing of hypotheses about etiologic 
factors, and 

— To complement similar smaller but less well standardized 
follow-up studies performed in different places and times. 

Proposals in response to the RFP are due July 8, 1983, and will be 
reviewed this sunmer and funded this fiscal year. Twenty-seven 
institutions have indicated their intent to submit proposals. The 
current FY 1983 budget includes $900,000 funds to support one contract 
in response to this RFP. 

Intramural ($1.8 million) 

Current FY 1983 intramural efforts involve a total estimated obligation 
of $1.8 million. Patients with each of the clinical forms of AIDS are 
being evaluated and intensely studied to determine the mechanisms and 
natural history of the iiniiunodeficiency and the consequent opportunistic 
infections. NIAID physicians are studying the immunoregulatory defect 
that occurs in patients with AIDS. This includes an evaluation of the 
excessive stimulation of itmunoglobulin production that is seen in 
contrast to the profound lack of T-helper cells in patients with this 
syndrome. Therapeutic approaches being undertaken by NIAID physicians 
with AIDS patients are antiviral agents; irmiunological reconstitution by 
'■one marrow transplantation or transfer of immune competent cells; and 
immunological enhancement by the use of factors such as interferon. An 
intensive effort to identify the etiologic agent of AIDS is underway. 
Chimpanzees have been inoculated with blood and other material from AIDS 
patients. Other NIAID scientists are studyina the itimune response 
following CMV infections, including the virus^ ability to reverse T- 
helper and T-suppressor cell ratios, and the sera of AIDS patients is 
being evaluated for the presence of antibodies to parvoviruses. 

PROPOSED ADDITIONAL NIAID FUNDS ($4.5 million) 

Extramural ($3.5 million) 

A total of $1.5 million is proposed for grants to be allocated in 
priority order among: 

Some of the 17 new research project grant applications deemed 
scientifically meritorious whi.h have been received recently. 
These applications will be reviewed by initial peer review groups 
this summer and by the NIAID Advisory Council either at their 
next (September) meeting, or by an earlier mail ballot. These 
applications include the following activities: virologic and 



26-097 0—83 26 

■■l»l»i» 



398 



iimiunologic evaluation of AIDS; autointnune anti-T helper activity 
in AIDS patients; immunobiology of AIDS; itimunoregulation in 
AIDS; semen -induced imunosuppression; antimicrobial imnunity in 
AIDS patients; and immunopathology of AIDS. 

Supplemaits to ongoing grants for research on the association of 
a number of virologic and parasitic infections and the immune 
dysfunction of AIDS patients. 

Payment of additional cooperative agreements from the NCI RFA 
might include: AIDS and the mechanism of defective 
iimiunoregulation; pathogenesis of Acquired Inmune Deficiency 
Syndrome; and herpes viruses and Immune responses in male 
homosexuals. 

An estimated $2.0 million for contracts would be used as follows: 

Supplementation of an existing contract on enteric diseases, to 
initiate studies on severe diarrheal problems associated with 
AIDS. 

Additional funds would allow NIAID to award three additional 

contracts from the RFP ("Study of the Natural History of AIDS in 

Homosexual Men"), issued May 9, 1983, and described under NIAID's 
current efforts. 

Intramural ($1.0 million) 

Additional resources for intramural research would permit NIAID to 
conduct a study of patients at risk of AIDS with collection of specimens 
for identification of etiologic agents and to initiate a clinical trial 
on the treatment of AIDS patients with alpha-interferon to correct 
immune defects. 

Total NIAID support for AIDS with the proposed additional funds would 
amount to $8.6 million in FY 1983: $5.8 million for extramural and $2.8 
million for intramural research. 

National Heart, Lung, and Blood Institute (NHLBI) 

CURRENT EFFORTS ($346,000) 

Extramural ($290,000) 

The NHLBI is currently supporting extramural research on AIDS in FY 1983 
as a part of the blood diseases and resources program. Specifically 
this support is divided among four areas: 

Support of a conference to be held in early August, jointly 
sponsored with NCI and NIAID, to discuss recent developments 
related to the epidemiology of AIDS. NHLBI 's special emphasis 
will be on possible transmission of the disorder by blood 



399 



products; the overall focus will be on epidemiologic, 
immunologic, virological and clinical aspects of AIDS. 

An intra-agency agreement with the Centers for Disease Control to 
determine whether AIDS may be transmitted through parenteral 
contact with blood and blood products and whether patients with 
heriDphllia and frequently transfused patients with sickle cell 
disease and thalassemia major display similar imnu no logic 
abnormalities. 

Support of a portion of a research project which utilizes current 
data to study sera from homosexual men who showed elevated levels 
of thymosin and beta-2-microglobulin. 

Support a study of the prevalence of itinunologic abnormalities in 
a large group of hemophilic patients and compare the 
abnormalities identified with fundings in hemophiliacs from other 
countries to determine whether this is an endemic problem within 
the United States. 

Intramural ($56 thousand) 

NHLBI is currently supporting a study at the Clinical Center, NIH, to 
determine if AIDS can be transmitted to chimpanzees by infusing the 
animals with plasma from human AIDS patients. There are no plans to 
increase intramural research efforts on AIDS in FY 1983. 

PROPOSED ADDITIONAL NHLBI FUNDS ($1.0 million) 

The Institute proposes to support a prospective study of 1,500 
homosexuals to measure thymosin and beta-2-microblobul1n levels in an 
at-risk population and to determine whether there are genetic factors, 
such as Human Leukocyte Antigen abnormalities, involved in a 
predisposition to AIDS. 

Total NHLBI AIDS resources for FY 1983, including the proposed 
additional funds would be $1.3 million for extramural and $56 thousand 
for intramural research. 



National Institute of Neurological and Communicative Disorders 
and Stroke (NINCDS) 

CURRENT EFFORTS ($72 thousand) 

Extramural (No current funding) 

The NINCDS does not support any extramural research grants directly 
relevant to AIDS research at this time, and there are no pending grant 
applications. 



400 



Intramural {$72 thousand) 

In Its current effort of clinical and laboratory research, the NINCDS 
has found that 255! of Kaposi AIDS patients have neurological 
complications such as central nervous system (CNS) infections-- 
cytomegalovirus (CMV), toxoplasmosis, and progressive multifocal 
leukoencephalopathy (PML). Investigations are being carried out on the 
interaction between viruses and the host immune-system to examine 
mechanisms of protection as well as disease production in the case of 
acute or chronic infections of the central nervous system. 

The NINCDS is collaborating with the California Primate Center to study 
AIDS in experimental animal models by examining tissue obtained from 
rhesus monkeys who have Simian Acquired Iimune Deficiency Syndrome, a 
disorder which may be similar to AIDS. In addition, our Institute staff 
are seeing patients admitted by the National Cancer Institute and the 
National Institute of Allergy and Infectious Diseases at the NIH to 
study the deterioration of neurological functions in patients with AIDS. 

PROPOSED ADDITIONAL NINCDS FUNDS ($545,000) 

Additional funds would provide for several initiatives, including 
purchase of equipment and isolation facilities modifications. An 
increase of $275 thousand is proposed for clinical studies of 
neurological findings in AIDS and Kaposi's sarcoma patients, since 
25% of these patients have neurological complications such as central 
nervous system infections of unknown cause. Seriological and virus 
isolation studies using new advanced tissue culture methods would be 
initiated. 

An additional $200 thousand would be used to study individuals during 
early prodromal stages of disease before the onset of opportunistic 
infections which obscure the primary infecting agents. 

An additional $70 thousand would be required in anticipation of the 
increased need for cortical biopsies and other clinical studies in 
order to investigate involvement of the central nervous system. 

The total FY 1983 NINCDS budget with the proposed additional funding 
would be $617 thousand^oie. fl /D5 /^<5S"^c^>. 



401 



The remaining support for AIDS research at NIH for FY 1983 is provided 
by the Division of Research Resources (DRR), the National Institute of 
Dental Research (NIDR) and the National Eye Institute (NEI). Support is 
provided extramurally by the DRR (an estimated $644,000 in 1983) 
primarily through its General Clinical Research Centers and primate 
centers, and intramurally at the National Institute of Dental Research 
(NIDR) and the National Eye Institute (NEI) within the Clinical Center 
at Bethesda. NIDR research, at $25,000 in 1983, is concerned with virus 
isolation and with abnormalities in the interferon system of AIDS 
patients. The NEI, with estimated expenditures of $45,000 in 1983, 1s 
involved with providing ocular care of AIDS patients and is studying the 
causes of the visual difficulties that frequently beset these patients. 

With the availability of additional funds, as outlined in Dr. Brandt's 
letter of May 18, 1983, to Mr. Natcher, NIH funding 'or AIDS in FY 1983 
would be nearly $19 million. (A sumnary table is attached.) 

With these resources, we are well positioned to provide a critical mass 
of resources to take advantage of the latest research opportunities 
involving AIDS. 



Sincerely yours. 




James B. Wyngaarden, M.D. 
Director 



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.^ 



DEPARTMENT OF HEALTH & HUMAN SERVICES 



Public Hnhh Service 



MAY I 8 1983 



Office of the Atsittant Secretary 

tor Heelih 
Washington DC 20201 



The Honorable William H. Natcher 

Chairman 

SJbcommittee on Labor, Health and 

Human Services, Education 

and Related Agencies 
Committee on Appropriations 
House of Representatives 
Washington, D.C. 20515 

Dear Kr . Chairman: 

I am responding to your letter of May 9, 1983, regarding 
Acquired Immune Deficiency Syndrome (AIDS). The enclosed status 
report (Fnrlosure 1), prepared by the Public Health Service 
(RMS'* on Airs, updates information provided to you by Depart- 
mental witnesses at the recently completed 1983 appropriations 
hearings. I am glad to have this opportunity to assure you that 
resources allocated to the campaign against AIDS are substantial, 
as indicated by the budget summary table, and the Department 
is committed to taking necessary actions. 

You also asked whether additional resources could effec- 
tively be used in the current fiscal year. As with any 
situation as dynamic and critical as that of AIDS, funding 
requirements can change rapidly. Enclosure 2 is a description 
of additional efforts which could be accomplished now and in 
future months. 



While we are not requesting additional budget authority for 
these items, we would not oppose Congress giving the Secretary 
of Health and Human Services discretionary authority to transfer 
up to $1?.0 million for AIDS activities across appropriation 
lines of HHS. We are currently requesting authority from the 
Office of Management and Budget for this purpose. 

I want to assure you that the problem of AIDS is indeed of 
major concern and interest to the Public Health Service. 

Sincerely yours, 




'dward N. Brandt, Jr., M.D. 
Assistant Secretary for Health 



Enclosures 



404 

I'PDATE ON ACQUIRED 1^'.ML■NE DEFICIENCY SYNDROME 
May 12. 1S83 

Identified AIDS esses: '.''0 

Case rate per Billion: o.3 

Mortality rate/2 yrs. diagnosis: '?* 

The c.use of this iz^uue dysfunction Is unknown, however, the occurrence of 
these di.o.ders ancng the high risk groups suggests that t*^* ""^«/» 
prctably an Infectious i^gcnt transritted sexually, or through blood or 
blood products. To date, no person to person transmission has been 
identified other than through intirate contact or blood transfusion. 
Studies have reported the following transmission patterns, paralleling the 
h»;at it is B virus: 

o sexually-transmitted among honosexual or bisexual men. 

o heterosexual transnission among women who are steady sexual partners 
of men with AIDS or of men in high risk groups, 

In vitro or perinatal transmissions in infants born to mothers fron 
high risk groups, 

transmission through blood or blood romponents such as hemophilia 
patients requiring clotting fartor replacement, drug abusers sharing 
contaminated needles, and blood products or blood transfusions. 

no AIDS cases have been reported among health care or laboratory 
personnel caring for AIDS patients or processing laboratory specinens. 

o very little Is known about risk factors for Haitians with AIDS. 

Since only a small percentage of high risk group members have AIDS, a 
laboratory test is clearly needed to Identify those with AIDS or those « 
highest risk of acquiring AIDS. Identification of a cause is hindered by 
latent periods of several months to 2 years between exposure and 
recognizable Illness. Work conducted by the Public Health Service h«c 
produced the following results: 

Nitrite Inhalants are probably not the cause of AIDS; aubstance 
is rarely used by heterosexual cases and does not cause 
Immunosuppressloo in alee. 

Marmosets and chimpanzees Inoculated with patient Mterlalt have 
remained well, to date, though fcllowup la leaa than eight 
■onths. 

— - Isaunologlcal paraactcTa of AIDS catea have been daf Ined. 

Including Identifying a cellular lamune deficiency raUtad to 
T-ccll function. 



o 



o 



405 



Relationship of AIDS and cyf omegalovl rus (CMV) has been 
clarified; CMV Is llktly an oprortunist Ic infection In AIDS cases 
and not the cause. 

Testing of blood products used by henophll laca (Factor VIII 
concentrate and cryopreclpl tate) have thus far been negative for 
etiologic agents, using available laboratory technology. 

Other virologlc and pathologic laboratory examinations of patient 
materials (blood, lymph nodes, autopsy speclraen) have not 
detected the cause, although rany such examinations are underway. 

Alrlicugh the cause of AIDS retains unlcnou-n, the PHS rtcomcnds the 
fCilcwing preliminary preventive actions: 

1. Sexual contact should be avoided with Individuals known or suspected 
to have AIDS. Multiple partners Increase the possibility of 
develuping AIDS. 

2. As a temporary neasure, meobers of risk groups should refrain froB 
derating plasca and/or blood. Collection centers should Inform 
potential donors. 

3. Studies should be conducted to evaluate screening procedures for their 
effectiveness In identifying and excluding plasma and blood with a 
high probability of transmitting AIDS. These procedures should 
Include specific laboratory tests as well as careful histories and 
physical exams. 

4. Physicians should adhere to medical Indications for transfusions, and 
autologous blood transfusions are encouraged. 

5. Work should continue towards the development of safer blood products 
for use by hemophilia patients. 

ONGOING PHS ACTIVITIES 

The objectives of the PHS activities are to determine the pathogenesis of 
AIDS, and how It Is transmitted and, finally to develop methods of 
prevention and control. When the AIDS problem was recognized In early 
1981, close liaison was established among the Public Health Service 
agencies with major responsibilities, each emphasizing Its primary mission: 
the Centers for Disease Control (CDC), surveillance and Investlgat loni ; the 
National Instltutea of Health (NIH), research into fundamental cause* and 
clinical aspects of AIDS; and the Food and Drug Administration (FDA), 
preventive measure! related to blood collection and lt« uae. CDC meets 
weekly to provide updates on the status of laboratory Investigations and 
research activities. When necessary, outside consultants isnd NIB and FDA 
personnel sre Invited to consult with and advise CDC oo AIB's activities. 
An loter-fnstltute NIH Working Croup, with active participation by CDC and 
FDA scientists, was established lo July 1982 to foster txchang* of 
scientific findings and to provide • ready channel to aak* current data 
available. A complementary working group coordinate* loforvatloo 



406 



collection and dl ssenlnat Ion. In addition, two major meetings have been 
held with representatives of the PHS agencies and a variety of outside 
scientists and representatives of concerned groups. A meeting on July 27, 
1982 led to the recoamendat Ion to Intensify surveillance of AIDS patient* 
with hemophilia, and to improve the quality of Factor VIII concentrate to 
decrease infectious risk. A sinllar meeting was held on January 4, 1983 In 
which a detailed set of approaches to prevention was discussed. This led 
to the publishing of PHS guidelines for the prevention of AIDS. 

Ci:S'TERS FOB DISEASE CONTROL 

The major responsibilities of CDC in the AIDS Investigation are to conduct 
furvtll lance, epldenlolcgi c studies and invest Igat lens , and laboratory 
investigations. The top priority of the Investigation Is to find the cause 

of AIDS. 

A. Survei 1 ' ance 

A surveillance system has been icplerented to receive case reports 
from physicians, herophllia treatment centers, and State and local 
health Departnents. A cooperative agreement has been established with 
the New York City Health Department to improve surveillance activities 
in the New York City metropolitan area. 

B. Epideriologic Studies 

Epideciologic studies to identify risk factors for AIDS In homosexual 
populations include a national case-control study and an analysis of 
clusters of sexually related cases which support the hypothesis of 
sexual transmission of an infectious agent. 

Epidemiologic studies and investigations are also being done of cases 
occurring among four other groups: (1) heterosexuals and their 
frequent sex partners. (2) Haitians. (3) intravenous drug abusers, and 
(4) hemophiliacs, as well as homosexual men with chronic unexplained 
lynphadenopathy, and "sub-cllnlcal immunosuppression". More than 100 
AIDS cases and 200 controls have been Interviewed by CDC 
epidemiologists. Results of Investigations of hemophilia patients and 
Intravenous drug abusers suggest transmission through blood and blood 
produccc. 

C. Laboratory Investigations 

Laboratory Investigations into the cause of AIDS Include Intensive 
vlrologlc, pathologic, and Immunologic studies. Inoculations of 
tissue from patients Into cell cultures and laboratory anlaal*, 
observation of these cultures and animals, and proloogcd l^unologlc 
and pathologic follow up of the animal* arc underway, btcnalvc 
laboratory Investigation of patient material* (blood, lyaph aodc*, 
autop*y apeclmen*) are being conducted u*lng highly •ephlatlcatcd 
method*. 



407 



NATIONAL INSTITUTES OF HEALTH 

A. Extramural Activities 

The N»tlon*l Cancer Institute (NCI) has Initiated a Clinical 
Corporative Research Awards project on etlologlc studies to support 
clinical research Into the caupes and prevention of AIDS. NCI has 
also gi\en high priority to grant-supported studies of Kaposi sarccnia 
and sicilar nialignant tumors related to AIDS. 

The National Institute of Allergies and Infectious Diicases (NTAID) is 
suppcrting research on cellular Innunology and regulation of the 
ir-tr.e svsteni; on deficiencies In the lrj;une systec; and on 
cytcnegalovlrus. 

The National Heart. Lung, and Blood Institute (NHLBI) Is studying the 
effect of AIDS patients' blood plasrea and other bodily fluids as 
administered to chlopanzees with the hope of identifying a causative 
agent. The Institute is expanding a study of blood recipients and 
plins to initiate studies of "serrogate tests" for AIDS, which cay 
lead to a method for screening blood prior to transfusion. 

Other coiiponents of NIH are also active In AIDS research. The 
National ' -' -' " ~^ > -. - . . _. 



lational Institute of Neurological and Communicative Disorders and 
troke (NINCDS) Is conducting research Into neurological aspects of 
ilDS, and the Division of Research Resources (DRR) is seeking to 
evelop animal models for AIDS. 



Intramural Activities 

Concurrent with the external research assault on AIDS, NIH's 
Intramural laboratory and clinical scientists mounted a 
Bult idisciplinary attack on the syndrome. The continuing internal 
collaboration at the Bethesda location involves at least 25 
investigators and their teams in a dozen laboratories, including those 
working directly with patients in the Clinical Center and the newly 
activated Aabulatory Care Research Facility (ACRF). 

At NCI : Researchers in the Laboratory of Pathology are examining 
tissue specimens taken from AIDS patients during surgery to examine 
the Inaunologlcal characteristics of certain AIDS-related lymphomas. 
The Field Studies and Statistics Program is conducting epidemiological 
studies of immunological profiles of healthy homosexual acn and 
profiles of hemophiliacs without symptoBS, as well as individuals with 
AIDS or members of population groups at risk of developing AIDS. 
Division of Cancer Treatment Investigators arc uclDg 
alpha-lymphoblastold Interferon la eomblnatlOB with chcaothcrapy to 
treat Kaposi sarcosa Id AIDS patlitnta. 

At wfPR: The rolea of viruses and lotcrfcroa la the himaa l^uoe 
•ystea disorders are hclag studied. The studies ladlcate that the 
AIDS patients examined have sbnoraalltlea In their Interferon systeas. 
These abnoraalltles art aeea a* • defect la the ability of the 



408 



lyiBpl.ocytes to produce Interferon (usuany of the ganma type), or as « 
cJEnlfJcant Increase In circulating Interferon (usually of the alpha 
type). 

At NINCDS: The Infectious Diseases Branch Is conducting clinical and 
laboratory research on AIDS. The Institute Is collaborating with the 
California Regional Primate Research Center on the exanlnatlon of 
tissue obtained from rhesus monkey who have Slnlan Acquired Imoune 
Deficiency Syndrome— a disorder which nay be similar to AIDS. 

At NTA1D: Intramural scientists are searching for an infectious agent 
or Agents that might trigger AIDS and are conducting Innunologlc 
studies. Several scientists are exaoinlng the Irj-.unoregulatory defect 
that occurs In these patients. In the Laboratory of Clinical 
Investigation, an evaluation of the role of herpes infections and 
Epstcln-Barr virus in relation to AIDS is under way. The Laboratory 
of Infectious Diseases is investigating the role of hepatitis In AIDS 
because virtually all AIDS patients have had hepatitis. NIAID 
scientists are also evaluating AIDS patients for parvoviruses, a group 
of DSA viruses. 

At NEl: Clinical Branch scientists are studying ocular lesions that 
occur in patients with AIDS. These studies have the dual purpose of 
deterr;ining whether there are distinctive ocular signs that might help 
in recognizing AIDS victims and in obtaining new clues to the role of 
the innune system In eye disease. 

At NHIBI: Scientists are examining plasma specimens In an attempt to 
transfer a causative agent or agents taken from AIDS patients in the 
Clinical Center to chimpanzees. The goal is to Isolate a 
transmissible. Infectious agent. 

C. InfoT-aation Dissemination and Scientific Workshops 

Because of the multiple approaches to the mystery of AIDS, mechanisms 
have been established to coordinate and expedite research aod 
Information exchange among agencies Involved, within the national 
scientific community, and throughout internal research efforts. The 
Office of the Scientific Director of NIAID haa complied a 
comprehensive bibliography of articles In the scientific literature OD 
AIDS and related disorders which Is updated periodically. The NIAID 
Office Is also planning a "Memorandum" to be published periodically 
for rapid dissemination of Information within the aclentiflc cosmiunlty 
00 findings and developments In AIDS research. 

Since the problems of AIDS aurfaced, NIH has convened three aajor 
•clentlflc workshops on the ayndrome— by DRR on animal Models for 
AIDS, by NHLBI to gain auggestlont for future atudlca on prevention of 
tranmlsalon of AIDS la blood and blood products, and hj NIAID to 
•tlmdlatc rcacarch In acarch of a cauaatlvc afcnt. All aactlnt* were 
open to the press and public. 



409 

ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) 
Public Health Service Current Level of Effort 
(Dollars in thousands) 



1983 
1982 Current 
Actual Level 



Centers for Disease Control: S2,000 $4,600 

Food and Drug Administration: 150 350 

National Institutes of Health: 

NCI 

NHBLI 

NIDR 

NINCDS 

NIAID 

NEI 

DRR 

Subtotal, NIH 3,355 9,582 

Alcohol, Drug Abuse and 
Mental Health Administration: 



2,400 


4,400 


5 


346 


25 


25 


31 


72 


297 


4,050 


33 


45 


564 


644 



Total, PHS S5,505 314,532 



410 



ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) 

Additional FY 1983 Activities 
(in priority order) 

(Dollars in thousands) 

1983 

;^gency Current Increment Revised 

A. Additional Activities 

1. Centers for Disease Control S4,600 +S2,225 S5,360 _1/ 

2. National Cancer Institute.... 4,400 +3,300 7,700 

3. National Institute of 

Allergy and Infectious 

Diseases 4,050 +4,500 8,550 

4. National Heart, Lung and 

Blood Institute 346 +1,030 1,376 

5. National Institute of 

Neurological and 

Communicative Disorders 

and Stroke 72 +545 617 

6. Alcohol, Drug Abuse and 

Mental Health Administration ^^ZZl •'•^OO 400 

Subtotal 513,468 $12,000 824,003 2./ 

B. Other Continuing AIDS Activities 

1. National Institute of 

Dental Research S 25 — S 25 

2. National Eye Institute 45 — 45 

3. Division of Research Resources. 644 -- 644 

4. Food and Drug Administration... 350 — 350 

Total, PHS 514,532 512,000 525,067 _1/ 

1/ Does not include 51,465,000 which was used from a variety of other 
~ CDC activities to respond on a timely basis to AIDS needs. 



411 

Dr. Brandt. So that in fact a number of events had occurred 

You are making it appear like we just suddenly woke up one 
day. In fact, we had a number of things occurring during this 
period of time. We are trying to be responsive. We are trying to do 
the job. And it seems Hke what we did is a perfectly reasonable 
thing to do if you are going to try to be responsive. 

Mr Weiss. Now, let me ask you to look at a memo dated March 
25, 1983, from the Director of the National Cancer Institute to the 
Director of the National Institutes of Health. Would you have that 
handy? 

Dr. Brandt. No, sir, I don't have it handy. 

Mr. Weiss. We will get it to you in just a moment. This was writ- 
ten prior to the Public Health Service officials' testimony before 
the Appropriations Subcommittee. It says, "NCI has already 
funded four applications"— in response to the August AIDS RFA 
totaling $369,000." 

I am going to rush through the first couple of lines. 

NCI and NIAID jointly are prepared to fund six additional 
grants. This will require a total of $1.8 million from NCI, and 
x?At u'^i^ ^^^^ NIAID. Money will be reprogrammed within the 
NCI budget to enable us to fund this high quality science since our 
original set-aside is exceeded by approximately $600,000. 

And then this line, "With this plan we will be able to fund 30 
percent of all approved applications for AIDS research," approved 
applications. 

That is as of March 25, 1983, prior to Dr. Foege's testimony 
before the subcommittee that you don't really need authorization 
for any new money. 

Dr. Brandt. Of course. Dr. Foege does not represent the NIH or 
NCI. He represents only the CDC; that is the agency he is Director 
of. So actually, Dr. Foege couldn't have commented on that. 

Mr. Weiss. But your testimony, Dr. Brandt, is that the reason for 
the change, for the request for $12 million, was the new application 
requests that came in to NIH. Now, did you need Mr. Natcher's 
letter of May 9 to point that out to you? 

Dr. Brandt. Well, certainly Mr. Natcher's letter to me requested 
of course a great deal of information. But it gave me an opportuni- 
ty to make our situation known to the subcommittee. 

Dr. Foege. Mr. Chairman? 

Mr. Weiss. Yes, Dr. Foege. 

Dr. Foege. If I try to explain the CDC portion of this and not try 
to explain any other— I pointed in my testimony that when we are 
in an emergency situation, where we do not have funding, we do in 
fact use money from other parts of CDC, and that in 1983 it was 
my estimate that while we would have $2 million appropriated, we 
would be spending at least that much extra from other parts of 
CDC. 

My request then a month later made an increase really from 
about $4 million plus to ask for an additional three-quarters of a 
million dollars for AIDS activity, and the remainder would be pay- 
back of what we had borrowed. So it was a fairly small increment 
of less than 20 percent. At the same time, during that period of 
time there were things happening that were causing us great con- 
cern. 



412 

No 1 we simply had no leads on an agent and we had been 
hoping that the extensive effort would provide some idea of the eti- 
ology. 

No 2 the numbers, instead of plateauing, were increasing, as 
you noted this morning, at a rate that was doubling about every 6 
months But there were two other things in that period of time 
that caused us concern. One was whether this problem was much 
bigger in terms of what we were then seeing in lymphadenopathy 
in people who did not have AIDS, and we had to do some extensive 
investigations to determine if this was a prodromal phase of AIDS, 
a midphase of AIDS, or totally unrelated to AIDS? 

Finally, the fourth thing that was concerning us at that time, the 
conviction that this was probably a virus, and, if so that it could be 
bloodborne. And we had in mind at that time that we might have 
to launch surveillance systems looking for cases. In fact, we talked 
about the possibility of hemophiliacs being at risk before we ever 
had the first case of AIDS in a hemophiliac. 

All of those things were happening in that time period. Because 
of that, I asked for an increase of less than 20 percent in the 
budget, because I did not think we could continue to borrow more 
from other parts of CDC. 

Mr. Weiss. I understand that. You must understand that my ex- 
pression of concern is not that you asked for too much money. 
Quite the contrary. What I am suggesting is that either there was 
an unwillingness to know, or in fact you did not know how much 
money you needed, that there seemed to be no comprehensive ap- 
proach to this problem, and that you were reacting almost on a 
day-to-day kind of basis, as Dr. Brandt said, rather than having 
planned and plotted out your work to see what in fact your needs 
were going to be. . 

I think that coming back and asking for a modest increase, 
having been pushed by the House to a great extent, was perfectly 
genuine and legitimate on your part. The question that I raise is 
why the discovery only when Mr. Natcher wrote to Dr. Brandt on 
May 9 and said, hey, reanalyze your position, and you say, OK, 
maybe we can use an extra $12 million at that. 

Dr. Brandt. I must admit the way you paint the picture, it 
doesn't sound very good. I have to agree with you, sir, in that re- 
spect. But, I don't think we were reacting on a day-to-day basis. 
What I said was, we were reviewing and analyzing on a week-by- 
week basis attempting to determine where we were. 

Things were happening at that time, narrowing in on the virus. 
We thought, therefore, we needed to take advantage of the opportu- 
nity. Congressman Natcher gave us that opportunity to do so. 

Mr. Weiss. Let me touch on another aspect of what we have just 
been talking about. 

There have been suggestions from the representative of the 
American Public Health Association, research physicians: Dr. 
Conant, and Dr. Voeller; and from affected communities that one 
of the problems seems to be that in fact there has been no effort to 
pull together the best scientific minds in this country, and with 
their cooperation, determine what a comprehensive approach ought 
to be. 



413 

Your responses here this morning have suggested a series of spo- 
radic kinds of meetings and the attitude, if you will pardon my 
paraphrasing, that "We know what we are doing. We know what is 
best. We don't really need anybody else from the outside to be 
pulled into this situation." 

If in fact your base of knowledge is as limited as you acknowl- 
edge it is, why not reach out, bring the best scientific and medical 
brains in, and set up a comprehensive approach to dealing with 
this crisis over the next year, the next 5 years. Or, leave out a 
timeframe and just discern what steps ought to be taken. 

Dr. Brandt. The issue, sir, is that we are doing that. That is the 
whole point that we have been bringing outstanding scientists in. 
Now the question of who is the best in terms of brains, perhaps Dr. 
Conant and I might disagree on who that is. But they are certainly 
brains that are capable of dealing with this problem that are out- 
side the Government. 

I mean these are people that have been brought in, and to whom 
we have gone to look at these areas. This is a complex problem. 
There is no one human being or no one scientist that is going to be 
able to look at the total picture from dealing with intricacies of 
blood to intricacies of virology. Therefore, we have brought in 
groups to address them, to develop these research agendas. We 
have outlined a lot of these. 

I am sorry that Dr. Conant does not think those people are com- 
petent. That is obviously his own opinion. I don't happen to share 
that. But we will continue to involve people that are competent. 
We have regular standing advisory committees; we have groups 
that are brought in specifically to deal with this problem. We will 
continue to do it. 

Mr. McCandless. Will the chairman yield? 

May I offer a suggestion for purposes of the record? 

In your answer to my question, you gave certain specific in- 
stances which you analogized to the question of bringing people to- 
gether for the common purpose. 

With your permission, Mr. Chairman, I would like to have sub- 
mitted for the record, whenever it is possible for Dr. Brandt, a list 
of these various meetings and who attended. I think it would di- 
rectly answer the question that you are asking and which I pre- 
sented earlier. 

Mr. Weiss. An excellent suggestion. 

Dr. Brandt. We will be more than delighted. I have tried to out- 
line them in my testimony. We will be more than delighted to send 
you all the names of the people who attended and let somebody de- 
termine whether or not they are qualified to give us advice. 

[Material referred to follows:] 



26-097 0-83 27 



414 



FDA 
Blood Products Advisory Conanittee Meetings 

September 23-24, 1982 
December 3 -A, 1982 
February 8, 1983 
March 1-2, 1983 
July 19, 1983 
BLOOD PRODUCTS ADVISORY COMMITTEE 



riu^.^^^cf-;^^ 1']^?, 



Chairman 

Hove, Joseph. R. , M.D. 

Director 

Blood Transfusion Service 

Yale-New Haven Hospital 

6007 Clinic Building 

20 York Street 

New Haven, CT 06510 



Members 



Haflelgh, Elizabeth B., 

B. A., MT(ASCP) 
Chief Technologist/Department Head 
Transfusion Service, P1099 
Stanford University Hospital 
Stanford University Medical Center 
Stanford, CA 94305 

Miller, Ronald D. , M.D. 
Professor, Anesthesia/Pharmacology 
Medical Science Building, Rm. 436 
Department of Anesthesia 
University of California 
San Francisco, CA 94143 

Miller, William V., M.D. 

Director 

American Red Cross Blood Servi